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Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial.

ABSTRACT: Importance:Propofol or a combination of a synthetic opioid and muscle relaxant are both recommended for premedication before neonatal intubation but have yet to be compared. Objective:To compare prolonged desaturation during neonatal nasotracheal intubation after premedication with atropine-propofol vs atropine-atracurium-sufentanil treatment. Design, Setting, and Participants:Multicenter, double-blind, randomized clinical trial (2012-2016) in 6 NICUs in France that included 173 neonates requiring nonemergency intubation. The study was interrupted due to expired study kits and lack of funding. Interventions:Eighty-nine participants were randomly assigned to the atropine-propofol group and 82 to the atropine-atracurium-sufentanil group before nasotracheal intubation. Main Outcomes and Measures:The primary outcome was prolonged desaturation (Spo2 <80% lasting > 60 seconds), using intention-to-treat analysis using mixed models. Secondary outcomes assessed the characteristics of the procedure and its tolerance. Results:Of 173 neonates randomized (mean gestational age, 30.6 weeks; mean birth weight, 1502 g; 71 girls), 171 (99%) completed the trial. Of 89 infants, 53 (59.6%) in the atropine-propofol group vs 54 of 82 (65.9%) in the atropine-atracurium-sufentanil group achieved the primary outcome (adjusted RD, -6.4; 95% CI, -21.0 to 8.1; P?=?.38). The atropine-propofol group had a longer mean procedure duration than did the atropine-atracurium-sufentanil group (adjusted RD, 1.7 minutes; 95% CI, 0.1-3.3 minutes; P?=?.04); a less frequent excellent quality of sedation rate, 51.7% (45 of 87) vs 92.6% (75 of 81; P?

SUBMITTER: Durrmeyer X

PROVIDER: S-EPMC6583687 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial.

Durrmeyer Xavier X Breinig Sophie S Claris Olivier O Tourneux Pierre P Alexandre Cénéric C Saliba Elie E Beuchée Alain A Jung Camille C Levy Corinne C Marchand-Martin Laetitia L Marcoux Marie-Odile MO Dechartres Agnes A Danan Claude C

JAMA 20180501 17

<h4>Importance</h4>Propofol or a combination of a synthetic opioid and muscle relaxant are both recommended for premedication before neonatal intubation but have yet to be compared.<h4>Objective</h4>To compare prolonged desaturation during neonatal nasotracheal intubation after premedication with atropine-propofol vs atropine-atracurium-sufentanil treatment.<h4>Design, setting, and participants</h4>Multicenter, double-blind, randomized clinical trial (2012-2016) in 6 NICUs in France that include ...[more]

PMID: 29715354

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Project description:BACKGROUND:Obstructive sleep apnea (OSA) is characterized by repetitive episodes of complete or partial obstruction of the upper airways during sleep. Conscious sedation for flexible bronchoscopy (FB) places patients in a sleep-like condition. We hypothesize that oxygen desaturation during flexible bronchoscopy may help to detect undiagnosed sleep apnea. METHODS:Single-centre, investigator-initiated and driven study including consecutive patients undergoing FB for clinical indication. Patients completed the Epworth Sleepiness Scale (ESS), Lausanne NoSAS score, STOP-BANG questionnaire and the Berlin questionnaire and underwent polygraphy within 7 days of FB. FB was performed under conscious sedation with propofol. Oxygen desaturation during bronchoscopy was measured with continuous monitoring of peripheral oxygen saturation with ixTrend (ixellence GmbH, Germany). RESULTS:145 patients were included in the study, 62% were male, and the average age was 65.8?±?1.1 years. The vast majority of patients (n?=?131, 90%) proved to fulfill OSA criteria based on polygraphy results: 52/131 patients (40%) had mild sleep apnea, 49/131 patients (37%) moderate sleep apnea and 30/131 patients (23%) severe sleep apnea. Patients with no oxygen desaturation had a significantly lower apnea-hypopnea index than patients with oxygen desaturation during bronchoscopy (AHI 11.94/h vs 21.02/h, p?=?0.011). This association remained significant when adjusting for the duration of bronchoscopy and propofol dose (p?=?0.023; 95% CI 1.382; 18.243) but did not hold when also adjusting for age and BMI. CONCLUSION:The severity of sleep apnea was associated to oxygen desaturation during flexible bronchoscopy under conscious sedation. Patients with oxygen desaturation during bronchoscopy might be considered for sleep apnea screening. TRIAL REGISTRATION:The Study was approved by the Ethics Committee northwest/central Switzerland, EKNZ (EK 16/13) and was carried out according to the Declaration of Helsinki and Good Clinical Practice guidelines. Due to its observational character, the study did not require registration at a clinical trial registry.

Project description:BackgroundDetermine if apneic oxygenation (AO) delivered via nasal cannula during the apneic phase of tracheal intubation (TI), reduces adverse TI-associated events (TIAEs) in children.MethodsAO was implemented across 14 pediatric intensive care units as a quality improvement intervention during 2016-2020. Implementation consisted of an intubation safety checklist, leadership endorsement, local champion, and data feedback to frontline clinicians. Standardized oxygen flow via nasal cannula for AO was as follows: 5 L/min for infants (< 1 year), 10 L/min for young children (1-7 years), and 15 L/min for older children (≥ 8 years). Outcomes were the occurrence of adverse TIAEs (primary) and hypoxemia (SpO2 < 80%, secondary).ResultsOf 6549 TIs during the study period, 2554 (39.0%) occurred during the pre-implementation phase and 3995 (61.0%) during post-implementation phase. AO utilization increased from 23 to 68%, p < 0.001. AO was utilized less often when intubating infants, those with a primary cardiac diagnosis or difficult airway features, and patient intubated due to respiratory or neurological failure or shock. Conversely, AO was used more often in TIs done for procedures and those assisted by video laryngoscopy. AO utilization was associated with a lower incidence of adverse TIAEs (AO 10.5% vs. without AO 13.5%, p < 0.001), aOR 0.75 (95% CI 0.58-0.98, p = 0.03) after adjusting for site clustering (primary analysis). However, after further adjusting for patient and provider characteristics (secondary analysis), AO utilization was not independently associated with the occurrence of adverse TIAEs: aOR 0.90, 95% CI 0.72-1.12, p = 0.33 and the occurrence of hypoxemia was not different: AO 14.2% versus without AO 15.2%, p = 0.43.ConclusionWhile AO use was associated with a lower occurrence of adverse TIAEs in children who required TI in the pediatric ICU after accounting for site-level clustering, this result may be explained by differences in patient, provider, and practice factors. Trial Registration Trial not registered.

Project description:BackgroundEstablishment of a secure airway is a critical part of neonatal resuscitation in the delivery room and the neonatal unit. Videolaryngoscopy has the potential to facilitate successful endotracheal intubation and decrease adverse consequences of delay in airway stabilization. Videolaryngoscopy may enhance visualization of the glottis and intubation success in neonates.ObjectivesTo determine the efficacy and safety of videolaryngoscopy compared to direct laryngoscopy in decreasing the time and attempts required for endotracheal intubation and increasing the success rate at first intubation in neonates.Search methodsWe used the search strategy of Cochrane Neonatal. In May 2017, we searched for randomized controlled trials (RCT) evaluating videolaryngoscopy for neonatal endotracheal intubation in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, abstracts of the Pediatric Academic Societies, websites for registered trials at www.clinicaltrials.gov and www.controlled-trials.com, and reference lists of relevant studies.Selection criteriaRCTs or quasi-RCTs in neonates evaluating videolaryngoscopy for endotracheal intubation compared with direct laryngoscopy.Data collection and analysisReview authors performed data collection and analysis as recommended by Cochrane Neonatal. Two review authors independently assessed studies identified by the search strategy for inclusion.We used the GRADE approach to assess the quality of evidence.Main resultsThe search yielded 7057 references of which we identified three RCTs for inclusion, four ongoing trials and one study awaiting classification. All three included RCTs compared videolaryngoscopy with direct laryngoscopy during intubation attempts by trainees.Time to intubation was similar between videolaryngoscopy and direct laryngoscopy (mean difference (MD) -0.62, 95% confidence interval (CI) -6.50 to 5.26; 2 studies; 311 intubations) (very low quality evidence). Videolaryngoscopy did not decrease the number of intubation attempts (MD -0.05, 95% CI -0.18 to 0.07; 2 studies; 427 intubations) (very low quality evidence). Moderate quality evidence suggested that videolaryngoscopy increased the success of intubation at first attempt (typical risk ratio (RR) 1.44, 95% CI 1.20 to 1.73; typical risk difference (RD) 0.19, 95% CI 0.10 to 0.28; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 4 to 10; 3 studies; 467 intubation attempts).Desaturation episodes during intubation attempts were similar between videolaryngoscopy and direct laryngoscopy (MD -0.76, 95% CI -5.74 to 4.23; 2 studies; 359 intubations) (low quality evidence). There was no difference in the incidence of airway trauma due to intubation attempts (RR 0.10, 95% CI 0.01 to 1.80; RD -0.04, 95% CI -0.09 to -0.00; 1 study; 213 intubations) (low quality evidence).There were no data available on other adverse effects of videolaryngoscopy.Authors' conclusionsModerate to very low quality evidence suggests that videolaryngoscopy increases the success of intubation in the first attempt but does not decrease the time to intubation or the number of attempts for intubation. However, these studies were conducted with trainees performing the intubations and these results highlight the potential usefulness of the videolaryngoscopy as a teaching tool. Well-designed, adequately powered RCTs are necessary to confirm efficacy and address safety and cost-effectiveness of videolaryngoscopy for endotracheal intubation in neonates by trainees and those proficient in direct laryngoscopy.

Project description:This study compares the performance of pediatricians and anesthetists in neonatal and pediatric endotracheal intubations (ETI) during simulated settings. Participants completed a questionnaire and performed an ETI scenario on a neonatal and a child manikin. The procedures were recorded with head cameras and cameras attached to standard laryngoscope blades. The outcomes were successful intubation, time to successful intubation, number of attempts, complications, total performance score, end-assessment rating, and an assessment whether the participant was sufficiently able to perform an ETI. Fifty-two pediatricians and 52 anesthetists were included. For the neonatal ETI, the rate of successful intubation was in favor of anesthetists although not significant. Anesthetists performed significantly better in all other outcomes. Of the pediatricians, 65% was rated sufficiently adept to perform a neonatal ETI vs 100% of the anesthetists. Pediatricians (29%) overestimated while anesthetists (33%) underestimated their performance in neonatal ETI. For the pediatric ETI, all outcomes were significantly better for anesthetists. Only 15% of all pediatricians were considered sufficiently able to perform pediatric ETI vs 94% of the anesthetists.Conclusion: Anesthetists are far more adept in performing ETI in neonates and children compared with pediatricians in a simulated setting. Complications are expected to occur less frequently and less seriously when anesthetists perform ETI. What is Known: • Endotracheal intubation (ETI) performed by inexperienced care providers can lead to unsuccessful and/or prolonged intubation attempts. This can cause complications such as hypoxemia, trauma to the oropharynx and larynx, and prolonged interruption of resuscitation, which results in a high morbidity/mortality. • Fifty to 60 real-life ETI procedures are needed before ETI can be performed with a 90% success rate. Despite this, 18% of providers still require some assistance even after performing 80 intubations. Skill fade will occur if there is too little exposure. What is New: • This study shows that, on both neonatal and child manikins, anesthetists perform better in ETI compared with pediatricians. Besides this, complications are expected to occur less frequently and less seriously when anesthetists are performing the ETIs on neonates and children. • In those countries where there are no clear interprofessional agreements made in general hospitals on who will perform ETI on neonates and children in acute care settings, these agreements are urgently necessary.

Dataset Information

Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial.

Publications

Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial.

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