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Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant).

ABSTRACT: BACKGROUND:To assess the arterial oxygen partial pressure (PaO2) at defined time points during preoxygenation and to compare high-flow heated humidified nasal oxygenation with standard preoxygenation using oxygen insufflation via a facemask for at least 5?minutes, before intubation during induction of general anesthesia. METHODS:This randomized, single-blinded, prospective study will be conducted in patients undergoing head and neck surgery. After standard monitoring, the artery catheter at the radial artery or dorsalis pedis artery will be placed and arterial blood gas analysis (ABGA) for baseline values will be performed simultaneously. Each group will be subjected to 1 of 2 preoxygenation methods (high-flow nasal cannula or simple facemask) for 5?minutes, and ABGA will be performed twice. After confirming intubation, we will start mechanical ventilation and check the vital signs and perform the final ABGA. DISCUSSION:This trial aims to examine the trajectory of PaO2 levels during the whole preoxygenation procedure and after intubation. We hypothesize that preoxygenation with the high-flow nasal cannula will be superior to that with the face mask. STUDY REGISTRATION:This trial was registered with the Clinical Trial Registry (NCT03896906; ClinicalTrials.gov).

SUBMITTER: Jo JY

PROVIDER: S-EPMC7220443 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant).

Jo Jun-Young JY Kim Wook-Jong WJ Ku Seungwoo S Choi Seong-Soo SS

Medicine 20200301 12

<h4>Background</h4>To assess the arterial oxygen partial pressure (PaO2) at defined time points during preoxygenation and to compare high-flow heated humidified nasal oxygenation with standard preoxygenation using oxygen insufflation via a facemask for at least 5 minutes, before intubation during induction of general anesthesia.<h4>Methods</h4>This randomized, single-blinded, prospective study will be conducted in patients undergoing head and neck surgery. After standard monitoring, the artery c ...[more]

PMID: 32195955

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Project description:BackgroundCritically ill patients with obesity may have an increased risk of difficult intubation and subsequent severe hypoxemia. We hypothesized that pre-oxygenation with noninvasive ventilation before intubation as compared with high-flow nasal cannula oxygen may decrease the risk of severe hypoxemia in patients with obesity.MethodsPost hoc subgroup analysis of critically ill patients with obesity (body mass index ≥ 30 kg·m-2) from a multicenter randomized controlled trial comparing preoxygenation with noninvasive ventilation and high-flow nasal oxygen before intubation of patients with acute hypoxemic respiratory failure (PaO2/FiO2 < 300 mm Hg). The primary outcome was the occurrence of severe hypoxemia (pulse oximetry < 80%) during the intubation procedure.ResultsAmong the 313 patients included in the original trial, 91 (29%) had obesity with a mean body mass index of 35 ± 5 kg·m-2. Patients with obesity were more likely to experience an episode of severe hypoxemia during intubation procedure than patients without obesity: 34% (31/91) vs. 22% (49/222); difference, 12%; 95% CI 1 to 23%; P = 0.03. Among patients with obesity, 40 received preoxygenation with noninvasive ventilation and 51 with high-flow nasal oxygen. Severe hypoxemia occurred in 15 patients (37%) with noninvasive ventilation and 16 patients (31%) with high-flow nasal oxygen (difference, 6%; 95% CI - 13 to 25%; P = 0.54). The lowest pulse oximetry values during intubation procedure were 87% [interquartile range, 77-93] with noninvasive ventilation and 86% [78-92] with high-flow nasal oxygen (P = 0.98). After multivariable analysis, factors independently associated with severe hypoxemia in patients with obesity were intubation difficulty scale > 5 points and respiratory primary failure as reason for admission.ConclusionsPatients with obesity and acute hypoxemic respiratory failure had an increased risk of severe hypoxemia during intubation procedure as compared to patients without obesity. However, preoxygenation with noninvasive ventilation may not reduce this risk compared with high-flow nasal oxygen. Trial registration Clinical trial number: NCT02668458 ( http://www.clinicaltrials.gov ).

Project description:BackgroundHypoxemia can occur during gastroscopy under intravenous anesthesia. The aim of this randomized controlled trial was to evaluate whether oxygenation using a nasal mask can reduce the incidence of hypoxemia during gastroscopy under intravenous anesthesia compared with a traditional nasal cannula.MethodsA total of 574 patients scheduled for gastroscopy under intravenous anesthesia were enrolled and randomly assigned to receive either a nasal mask or a traditional nasal cannula for oxygenation. The primary outcome was the incidence of hypoxemia. The secondary outcomes included the incidence of severe hypoxemia, duration of hypoxemia, minimum oxygen saturation, the proportion of emergency airway management, length of procedure, recovery time, and the satisfaction of the anesthetist and gastroenterologists as well as other adverse events (including cough, hiccups, nausea and vomiting, reflux, aspiration, and laryngospasm).ResultsA total of 565 patients were included in the analysis: 282 patients in the nasal cannula group and 283 patients in the nasal mask group. The incidence of hypoxemia was lower in the nasal mask group (18.0%) than in the nasal cannula group (27.7%; relative risk [RR] = 0.65; 95% confidence interval [CI], 0.48-0.89; P = .006), and the hypoxemia lasted a median of 18.0 seconds (interquartile range, 10.0-38.8) in the nasal mask group and 32.5 seconds (20.0-53.5) in the nasal cannula group (median difference -14.50; 95% CI, -22.82 to -1.34; P = .047). The proportion of patients requiring emergency airway management was significantly lower in the nasal mask group (8.8%) than in the nasal cannula group (19.1%; RR, 0.46; 95% CI, 0.30-0.73; P < .001). No difference was found in the overall incidence of other adverse events between the 2 groups (nasal mask 20.8%; nasal cannula 17.0%; RR, 1.23; 95% CI, 0.87-1.73; P = .25). Satisfaction was higher with the nasal mask than with the nasal cannula from the perspective of anesthetists (96.1% for nasal mask versus 84.4% for nasal cannula; RR, 1.14; 95% CI, 1.08-1.20; P < .001) and gastroenterologists (95.4% for mask versus 81.9% for cannula; RR, 1.17; 95% CI, 1.10-1.24; P < .001). There were no significant differences in the incidence of severe hypoxemia, minimum oxygen saturation, length of procedure, or recovery time between the 2 groups.ConclusionsNasal mask oxygenation reduced the incidence of hypoxemia during anesthesia for gastroscopy under intravenous anesthesia.

Project description:Background:Several studies have identified side effects of general anesthesia with endotracheal intubation, such as laryngeal pain, dysphonia, and postoperative nausea and vomiting (PONV). The laryngeal mask airway (LMAw) is believed to decrease these side effects. The aim of this trial was to compare postoperative discomfort, emergence delirium, and recovery time of patients who received either an LMAw or nasotracheal intubation (NTI). Patients and methods:A total of 70 children were randomly assigned to the LMAw group (n=35) or the NTI group (n=35). Both groups underwent mask induction with 8% sevoflurane. The NTI group received muscle relaxant, whereas the LMAw group did not. Postoperative laryngeal pain, dental pain, dysphonia, and PONV were assessed immediately and at 1 hour and 6 hours postoperatively. The Wong-Baker Faces Scale was used to evaluate the patients' self-reported pain. In addition, decayed, missing, and filled teeth (dft/DMFT) values, dental procedure type, number of dental procedures, duration of the dental operation, duration of anesthesia, recovery time, emergence delirium, pediatric dentist's access to the mouth, and parents' satisfaction levels were recorded. Data were analyzed using descriptive statistics, chi-square tests, and two-sample t-tests. Results:The incidence of postoperative laryngeal pain was significantly higher in the NTI group immediately (97.2% vs. 8.5%, P=0.00), 1 hour (94.2% vs. 0%, P=0.00), and 6 hours postoperatively (25.7% vs. 0%, P=0.00). There were no statistically significant differences between the two groups in dental pain scores, dft/DMFT values, duration of anesthesia, duration of the dental operation, number of dental procedures, the incidence of PONV, or pediatric dentist's access to the mouth (P>0.05). Emergence delirium and recovery time were significantly higher in the NTI group (P<0.05). Conclusion:The LMAw provided a more comfortable postoperative period than NTI for children who underwent full-mouth dental rehabilitation under general anesthesia.

Project description:Background and objectivesPreoxygenation is crucial for providing sufficient oxygen reservoir to a patient before intubation and enables the extension of the period between breathing termination and critical desaturation (safe apnoea time). Conventionally, face mask ventilation is used for preoxygenation. Non-invasive ventilation is a new preoxygenation method. The study objective was to compare the outcomes of non-invasive ventilation and face mask ventilation for preoxygenation.MethodPubMed, Embase, Cochrane Library, and the ClinicalTrials.gov registry were searched for eligible studies published from database inception to September 2021. Individual effect sizes were standardized, and a meta-analysis was conducted using random effects models to calculate the pooled effect size. Inclusion criteria were randomised controlled trials of comparing the outcomes of non-invasive ventilation or face mask ventilation for preoxygenation in patients scheduled for surgeries. The primary outcome was safe apnea time, and the secondary outcomes were post-operative complications, number of patients who achieved the expired O2 fraction (FeO2) after 3 min of preoxygenation, minimal SpO2 during tracheal intubation, partial pressure of oxygen in the arterial blood (PaO2) and partial pressure of carbon dioxide (PaCO2) after preoxygenation, and PaO2 and PaCO2 after tracheal intubation.Results13 trials were eligible for inclusion in this study. Significant differences were observed in safe apnoea time, number of patients who achieved FeO2 90% after preoxygenation for 3 min, and PaO2 and PaCO2 after preoxygenation and tracheal intubation. Only in the non-obese subgroup, no significant difference was observed in safe apnoea time (mean difference: 125.38, 95% confidence interval: - 12.26 to 263.03).ConclusionNon-invasive ventilation appeared to be more effective than conventional methods for preoxygenation. We recommend non-invasive ventilation based on our results.

Dataset Information

Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant).

Publications

Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant).

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