Endotracheal intubation in elective cervical surgery: A randomized, controlled, assessor-blinded study.
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ABSTRACT:
SUBMITTER: Fan H
PROVIDER: S-EPMC5671810 | biostudies-other | 2017 Oct
REPOSITORIES: biostudies-other
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Endotracheal intubation in elective cervical surgery: A randomized, controlled, assessor-blinded study.
Fan Hongna H Cao Huijuan H Sun Yingjie Y Chen Keyan K Diao Yugang Y Zhou Nan N Yao Guoquan G Zhou Jin J Zhang Tiezheng T
Medicine 20171001 43
<h4>Background</h4>We compared the effectiveness and safety of endotracheal intubation using the GlideScope (GS) video laryngoscope, CTrach laryngeal mask airway (LMA), or Shikani optical stylet rigid laryngoscope (SOS) during elective cervical surgery.<h4>Methods</h4>Forty-five patients undergoing elective cervical surgery were randomly and equally assigned to endotracheal intubation via GS, LMA, or SOS airway management.<h4>Results</h4>Endotracheal intubation was successfully completed in all ...[more]
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Project description:BackgroundTopical anesthesia is a crucial step in awake endotracheal intubation for providing favorable intubation conditions. The standard of care technique for awake intubation at our institution, which consists of oropharyngeal tetracaine spray, can result in inadequate mucosal anesthesia. Therefore, we sought to compare the effectiveness of dyclonine hydrochloride mucilage to the standard of care tetracaine in achieving anesthesia of the upper airways for awake endotracheal intubation.MethodsThis is a randomized, assessor-blinded, prospective study. From Jun. 1st, 2019 to Aug. 1st, 2019, patients scheduled for either endoscopic submucosal dissection or peroral endoscopic myotomy were enrolled and randomly allocated into two groups after obtaining written informed consent: patients allocated to novel awake intubation care (Group N-AIC) received a single administration of oral dyclonine hydrochloride mucilage, whereas patients allocated to standard awake intubation care (Group S-AIC) received three oropharyngeal tetracaine sprays before transcricoid tetracaine injection before awake intubation. Mean arterial pressure (MAP), which was the primary outcome of this study, as well as heart rate (HR) were recorded throughout the procedure and compared between the two groups. Feeling of numbness, nausea, and intubation conditions after topical anesthesia were also assessed.ResultsSixty patients were enrolled and completed the study. Baseline MAP and HR were similar between the two groups. However, hemodynamic responses to intubation and gastrointestinal endoscopy, especially MAP, were significantly less elevated in Group N-AIC. The degree of numbness of the oropharyngeal mucosa after topical anesthesia did not differ between the two groups, neither did the feeling of nausea during laryngoscopy. The amount of pharyngeal secretions before intubation was less in Group N-AIC. Total intubation time was significantly shorter in Group N-AIC when compared to Group S-AIC (18.4 ± 2.86 vs. 22.3 ± 6.47, P < 0.05). Extubation bucking was significantly less frequent in Group N-AIC (13.3% vs. 76.7%). Patients received in Group N-AIC had a lower rate of post-extubation sore throat compared to Group S-AIC (6.7% vs. 43.3%). No adverse side effects attributable to either tetracaine or dyclonine were observed in this study.ConclusionsIn awake endotracheal intubation, novel care using oral dyclonine hydrochloride mucilage can provide more favorable mucosal anesthesia and better intubation conditions compared to standard of care practice using oropharyngeal tetracaine spray.Trial registrationChiCTR1900023151 . Date of registration: May 14th, 2019.
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Project description:INTRODUCTION:The optimal method to train novice learners to perform endotracheal intubation (ETI) is unknown. The study objective was to compare two models: unembalmed cadaver vs simulation manikin. METHODS:Fourth-year medical students, stratified by baseline ETI experience, were randomized 1:1 to train on a cadaver or simulation manikin. Students were tested and video recorded on a separate cadaver; two reviewers, blinded to the intervention, assessed the videos. Primary outcome was time to successful ETI, analyzed with a Cox proportional hazards model. Authors also compared percentage of glottic opening (POGO), number of ETI attempts, learner confidence, and satisfaction. RESULTS:Of 97 students randomized, 78 were included in the final analysis. Median time to ETI did not differ significantly (hazard ratio [HR] 1.1; 95% CI [confidence interval], 0.7-1.8): cadaver group = 34.5 seconds (interquartile ratio [IQR]: 23.3-55.8) vs manikin group = 35.5 seconds (IQR: 23.8-80.5), with no difference in first-pass success (odds ratio [OR] = 1; 95% CI, 0.1-7.5) or median POGO: 80% cadaver vs 90% manikin (95% CI, -14-34%). Satisfaction was higher for cadavers (median difference = 0.5; p = 0.002; 95% CI, 0-1) as was change in student confidence (median difference = 0.5; p = 0.03; 95% CI, 0-1). Students rating their confidence a 5 ("extremely confident") demonstrated decreased time to ETI (HR = 4.2; 95% CI, 1.0-17.2). CONCLUSION:Manikin and cadaver training models for ETI produced similar time to ETI, POGO, and first-pass success. Cadaver training was associated with increased student satisfaction and confidence; subjects with the highest confidence level demonstrated decreased time to ETI.
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Project description:BackgroundData on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (with both Macintosh-shaped and hyperangulated blades) is at least equal to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.MethodsIn this randomized, controlled, three-armed parallel group design, multi-centre trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to the standard of care (direct laryngoscopy with Macintosh blade). In a pre-defined hierarchical analysis, we will test the primary outcome for non-inferiority first. If this goal should be met, the design and projected statistical power also allow for subsequent testing for superiority of one of the interventions. Various secondary outcomes will account for patient safety considerations as well as human factors interactions within the provider team and will allow for further exploratory data analysis and hypothesis generation.DiscussionThis randomized controlled trial will provide a solid base of data in a field where reliable evidence is of major clinical importance. With thousands of endotracheal intubations performed every day in operating rooms around the world, every bit of performance improvement translates into increased patient safety and comfort and may eventually prevent significant burden of disease. Therefore, we feel confident that a large trial has the potential to considerably benefit patients and anaesthetists alike.Trial registrationClincalTrials.gov NCT05228288.Protocol version1.1, November 15, 2021.
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Project description:BackgroundFrailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery.MethodsPatients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention.DiscussionPrehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery.Trial registrationClinicalTrials.gov NCT04418271 . Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820.
| S-EPMC9167908 | biostudies-literature
Project description:Cognitive decline after cardiac surgery remains common and diminishes patients' quality of life. Based on experimental and clinical evidence, this study assessed the potential of intravenously administered lidocaine to reduce postoperative cognitive dysfunction after cardiac surgery using cardiopulmonary bypass.After IRB approval, 277 patients undergoing cardiac surgery were enrolled into this prospective, randomized, double-blinded placebo controlled clinical trial. Subjects were randomized to receive: (1) Lidocaine as a 1 mg/kg bolus followed by a continuous infusion through 48 hours postoperatively, or (2) Placebo bolus and infusion. Cognitive function was assessed preoperatively and again at 6 weeks and 1 year postoperatively. The effect of lidocaine on postoperative cognition was tested using multivariable regression modeling; P<0.05 was considered significant.Among the 241 allocated subjects (Lidocaine: n=114; Placebo: n=127), the incidence of cognitive deficit in the lidocaine group was 45.5% versus 45.7% in the placebo group (P=0.97). Multivariable analysis revealed a significant interaction between treatment group and diabetes, such that diabetic subjects receiving lidocaine were more likely to suffer cognitive decline (P=0.004). Secondary analysis identified total lidocaine dose (mg/kg) as a significant predictor of cognitive decline and also revealed a protective effect of lower dose lidocaine in nondiabetic subjects.Lidocaine administered during and after cardiac surgery does not reduce the high rate of postoperative cognitive dysfunction. Higher doses of lidocaine and diabetic status were independent predictors of cognitive decline. Protective effects of lower dose lidocaine in nondiabetic subjects need to be further evaluated.
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Project description:Dexmedetomidine is an alpha-2 adrenergic agonist with sedative, anxiolytic, and analgesic properties. This study was designed to evaluate the inhibitory effects of preoperative administration of 0.5 µg/kg dexmedetomidine on hemodynamic responses caused by endotracheal intubation in elderly patients undergoing treatment for hypertension.Forty elderly (? 65 years old) patients who had been receiving hypertension treatment, had American Society of Anesthesiologists physical status II, and were scheduled to undergo elective noncardiac surgery were randomly selected and assigned to 2 groups. Group C received normal saline and group D received 0.5 µg/kg dexmedetomidine intravenously over 10 min just before endotracheal intubation. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) were recorded preoperatively in the ward, immediately after study drug administration, and at 1, 3, and 5 min after endotracheal intubation.Compared to group C, group D showed significantly lower SBP and MAP at 1, 3, and 5 min as well as significantly lower DBP and HR at 3 and 5 min after endotracheal intubation.In elderly patients receiving hypertension treatment, a single preanesthetic dose of dexmedetomidine (0.5 µg/kg) effectively suppressed the hemodynamic responses to endotracheal intubation.
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Project description:BACKGROUND AND AIMS:The Airtraq™ optical laryngoscope is the only marketed videolaryngoscope for paediatric patients besides the fibre-optic bronchoscope. We hypothesized that intubation would be easier with Airtraq™ compared to Miller blade. Hence, we compared Airtraq™ with the Miller laryngoscope as intubation devices in paediatric patients. METHODS:This prospective, randomized study was conducted in a tertiary care teaching hospital. Sixty children belonging to American Society of Anesthesiologists' Grade I-II, aged 2-10 years, posted for routine surgery requiring tracheal intubation were randomly allocated to undergo intubation using a Miller (n = 30) or Airtraq™ (n = 30) laryngoscope. The primary outcome measure was time of intubation. We also measured ease of intubation, number of attempts, percentage of glottic opening score (POGO), haemodynamic changes and airway trauma. Student t test was used to analyse parametric data. RESULTS:Intubation time was comparable between Miller's laryngoscope (15.13 ± 1.33s) compared to Airtraq™ (11.53 ± 0.49 s) (P = 0.29) The number of first and second attempts at intubation were 25 and 5 for the Miller laryngoscope and 29 and 1 for the Airtraq™. Median visual analogue score (VAS) for ease of intubation was 5 in Miller group compared to 3 in Airtraq™ group. The median POGO score was 75 in the Miller group and 100 in the Airtraq™ group (P = 0.01). Haemodynamic changes were maximum and most significant immediately and 1 min after intubation. Airway trauma occurred in three patients (9.09%) in Miller group and one patient (3.33%) in Airtraq™ group. CONCLUSION:The Airtraq™ reduced the difficulty of tracheal intubation and degree of haemodynamic stimulation compared to the Miller laryngoscope in paediatric patients.
| S-EPMC5416723 | biostudies-literature
Project description:BackgroundRoutine endotracheal intubation requires a patient in supine position with an operator standing behind the patient's head. In case of a morbidly obese patient positioned in the recommended semi-recumbent position, an alternative method can be considered. Face-to-face intubation can be used both in patients in sitting as well as in prone position and when there is difficult access to the head. Evaluation of effectiveness and safety of face-to-face intubation in morbidly obese adult patients with body mass index over 40 kg m-2.MethodsThe study was approved by the Local Ethics Committee and written informed consent from patients was obtained. We conducted a parallel randomized controlled trial with patients scheduled for elective sleeve gastrectomy. The trial was registered in ClinicalTrials with a number NCT04959149. Randomization and allocation to trial groups were carried out using the envelope method. The primary outcomes were the time of intubation and the first pass success of endotracheal intubation.Results76 patients (routine intubation n = 36, face-to-face intubation n = 40) were included in the study with no dropouts. The intubation success rates were 82.5% versus 100%, mean intubation time was 17.1 ± 18 seconds versus 29 ± 11 seconds and the need for additional maneuvers (backward, upward, rightward pressure or flexing the neck) was 15% versus 19.5%, in face-to-face and routine intubation, respectively. No injuries to teeth or mucosa have been reported. There were no incidents of desaturation below 92% or other complications associated with intubation.ConclusionFace-to-face intubation is shorter than the routine intubation in obese patients. This method may be an alternative to standard intubation in case of airway management in morbidly obese patients in semi-erect position; however, it requires both training and practice.
| S-EPMC9726369 | biostudies-literature
Project description:The purpose of this study was to compare the efficacy and safety of dexmedetomidine versus remifentanil for sedation during awake intubation using a Shikani optical stylet (SOS).Sixty-eight patients with cervical trauma or severe cervical spondylosis undergoing cervical spinal surgery were enrolled in this prospective study. They were randomly assigned to receive dexmedetomidine (Group D) or remifentanil (Group R). In Group D, the patients received an intravenous loading dose of dexmedetomidine 1 μg · kg(-1) over 10 min followed by a continuous infusion of 0.7 μg · kg(-1) · h(-1). In Group R, a target-controlled infusion of remifentanil was administered to achieve a plasma concentration of 2.5 ng · ml(-1), increased to 3 ng · ml(-1) 10 min later. An endotracheal tube was inserted using a SOS under dexmedetomidine or remifentanil sedation after topical anesthesia to the airway. Midazolam was given as rescue sedation. We recorded the first attempt intubation success rate, the dose of midazolam, duration of intubation, Ramsay Sedation Scale (RSS) score, tracheal tube tolerance score, duration of drug infusion, adverse events and patient satisfaction score.The RSS score was significantly higher in Group D than in Group R. First attempt success rate, rescue midazolam dose and the duration of intubation did not differ between the groups. Patients in Group R were significantly more tolerant of the tracheal tube. The incidence of hypoxia was significantly higher in Group R than Group D, but there was no significant difference in the incidence of other adverse events between the groups. The hemodynamic responses of the two groups were similar, but more patients in Group R were able to recall airway instrumentation.Both dexmedetomidine and remifentanil are effective sedatives for awake intubation using an SOS. Although the first attempt success rates were similar, patients sedated with remifentanil tolerated the tracheal tube better after intubation with moderately increased risk of desaturation.www.chictr.org.cn ; ChiCTR-TRC-13003052 (February 4th, 2013).
| S-EPMC4970200 | biostudies-other
Project description:BACKGROUND:The benefits of high-flow nasal cannula (HFNC) as primary intervention in patients with acute hypoxemic respiratory failure (AHRF) are still a matter in debate. Our objective was to compare HFNC therapy versus conventional oxygen therapy (COT) in the prevention of endotracheal intubation in this group of patients. METHODS:An open-label, controlled and single-centre clinical trial was conducted in patients with severe AHRF, defined by a PaO2/FIO2 ratio ?200, to compare HFNC with a control group (CG) treated by COT delivered through a face mask, with the need to perform intubation as the primary outcome. The secondary outcomes included tolerance of the HFNC device and to look for the predictive factors for intubation in these patients. RESULTS:A total of 46 patients were included (22 in the COT group and 24 in the HFNC group) 48% of whom needed intubation: 63% in the COT group and 33% in the HFNC group, with significant differences both in intention to treat [?2?=?4.2; p?=?0.04, relative risk (RR)?=?0.5; confidence interval (CI) 95%: 0.3-1.0] and also in treatment analysis (?2?=?4.7; p?=?0.03; RR?=?0.5; IC 95%: 0.3-0.9) We obtained a number needed to treat (NNT)?=?3 patients treated to avoid an intubation. Intubation occurred significantly later in the HFNC group. Estimated PaO2/FIO2, respiratory rate and dyspnea were significantly better in the HFNC group. Patients treated with HFNC who required intubation presented significant worsening after the first 8?h, as compared with non-intubated HFNC group patients. Mortality was 22% with no differences. The HFNC group patients were hospitalized for almost half of the time in the intensive care unit (ICU) and in the ward, with significantly less hospital length of stay. A total of 14 patients in the HFNC group (58%) complained of excessive heat and 17% of noise; 3 patients did not tolerate HFNC. CONCLUSION:Patients with severe acute hypoxemic respiratory failure who tolerate HFNC present a significantly lower need for endotracheal intubation compared with conventional oxygen therapy. CLINICAL TRIAL REGISTER:EUDRA CT number: 2012-001671-36The reviews of this paper are available via the supplemental material section.
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