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Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol.

ABSTRACT: Endotracheal intubation in intensive care unit (ICU) is a procedure at high risk of life-threatening complications. Among them, severe oxygen desaturation, usually defined as a drop of pulse oxymetry (SpO2) below 80%, is the most common. Preoxygenation enables delaying oxygen desaturation occurring during apnea induced by anaesthetic drugs. Data suggest that non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy could further increase PaO2 before intubation procedure and prevent oxygen desaturation episodes as compared with standard oxygen. However, no recommendation favours one technique rather than the other, since they have never been compared. Hence, whether a strategy of preoxygenation with NIV or HFNC is more effective than the other in patients with acute hypoxaemic respiratory failure remains to be established.The FLORALI-2 study is a multicentre randomised controlled trial comparing a preoxygenation strategy with either NIV or HFNC in patients with acute hypoxaemic respiratory failure needing intubation in ICU. The 320 patients will be randomised with a ratio 1:1 in two groups according to the strategy of preoxygenation. The primary outcome is the occurrence of an episode of severe oxygen desaturation defined by a drop of SpO2 below 80% during the intubation procedure. Secondary outcomes include feasibility of the two strategies, immediate and late complications related to intubation.The study has been approved by the central ethics committee (Ethics Committee Ouest-III, Poitiers, France) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.NCT02668458; Pre-results.

SUBMITTER: Frat JP

PROVIDER: S-EPMC5770951 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol.

Frat Jean-Pierre JP Ricard Jean-Damien JD Coudroy Rémi R Robert René R Ragot Stéphanie S Thille Arnaud W AW

BMJ open 20171222 12

<h4>Introduction</h4>Endotracheal intubation in intensive care unit (ICU) is a procedure at high risk of life-threatening complications. Among them, severe oxygen desaturation, usually defined as a drop of pulse oxymetry (SpO<sub>2</sub>) below 80%, is the most common. Preoxygenation enables delaying oxygen desaturation occurring during apnea induced by anaesthetic drugs. Data suggest that non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy could further increase PaO< ...[more]

PMID: 29275345

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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:IntroductionTracheal intubation in the intensive care unit (ICU) is associated with severe life-threatening complications including severe hypoxaemia. Preoxygenation before intubation has been recommended in order to decrease such complications. Non-invasive ventilation (NIV)-assisted preoxygenation allows increased oxygen saturation during the intubation procedure, by applying a positive end-expiratory pressure (PEEP) to prevent alveolar derecruitment. However, the NIV mask has to be taken off after preoxygenation to allow the passage of the tube through the mouth. The patient with hypoxaemia does not receive oxygen during this period, at risk of major hypoxaemia. High-flow nasal cannula oxygen therapy (HFNC) has a potential for apnoeic oxygenation during the apnoea period following the preoxygenation with NIV. Whether application of HFNC combined with NIV is more effective at reducing oxygen desaturation during the intubation procedure compared with NIV alone for preoxygenation in patients with hypoxaemia in the ICU with acute respiratory failure remains to be established.Methods and analysisThe HFNC combined to NIV for decreasing oxygen desaturation during the intubation procedure in patients with hypoxaemia in the ICU (OPTINIV) trial is an investigator-initiated monocentre randomised controlled two-arm trial with assessor-blinded outcome assessment. The OPTINIV trial randomises 50 patients with hypoxaemia requiring orotracheal intubation for acute respiratory failure to receive NIV (pressure support=10, PEEP=5, fractional inspired oxygen (FiO2)=100%) combined with HFNC (flow=60 L/min, FiO2=100%, interventional group) or NIV alone (reference group) for preoxygenation. The primary outcome is lowest oxygen saturation during the intubation procedure. Secondary outcomes are intubation-related complications, quality of preoxygenation and ICU mortality.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (CPP Sud-Méditerranée). Informed consent is required. If combined application of HFNC and NIV for preoxygenation of patients with hypoxaemia in the ICU proves superior to NIV preoxygenation, its use will become standard practice, thereby decreasing hypoxaemia during the intubation procedure and potential complications related to intubation.Trial registration numberNCT02530957.

Project description:BackgroundIn obese patients, preoxygenation with non-invasive ventilation (NIV) was reported to improve outcomes compared with facemask. In this setting, high-flow nasal cannulae (HFNC) used before and during intubation has never been studied against NIV.MethodsThe PREOPTIPOP study is a randomised, single-centre, open-labelled, controlled trial including obese patients requiring intubation before scheduled surgery. Patients were randomised to receive preoxygenation by HFNC or NIV. HFNC was maintained throughout intubation whereas NIV was removed when apnea occurred to perform laryngoscopy. The study was designed to assess the superiority of HNFC. The primary outcome was the lowest level of end-tidal oxygen concentration (EtO2) within 2 min after intubation. Secondary outcomes included drop in pulse oximetry and complications related to intubation.Main findingsA total of 100 patients were randomised. The intent-to-treat analysis found median [IQR] lowest EtO2 of 76% [66-82] for HFNC and 88% [82-90] for NIV (mean difference - 12·1 [- 15·1 to - 8·5], p < 0·0001). Mild desaturation below 95% was more frequent with HFNC (30%) than with NIV (12%) (relative risk 2·5, IC 95% [1·1 to 5·9], p = 0·03) and median lowest SpO2 during intubation was 98% [93-99] in HFNC vs. 99% [97-100] in NIV (p = 0·03). Severe and moderate complications were not different but patients reported more discomfort with NIV (28%) vs. HFNC (4%), p = 0·001.InterpretationCompared with NIV, preoxygenation with HFNC in obese patients provided lower EtO2 after intubation and a higher rate of desaturation < 95%.FundingInstitutional funding, additional grant from Fisher & Paykel.Trial registrationClinical trial Submission: April 10, 2017. Registry name: Preoxygenation Optimization in Obese Patients: High-flow Nasal Cannulae Oxygen Versus Non-invasive Ventilation: A Single-centre Randomised Controlled Study. The PREOPTIPOP Study. Clinicaltrials.gov identifier: NCT03106441 N°ID RCB: 2017-A00305-48. Institutional review Board: CPP Nord-Ouest I, registration number 019/2017. URL registry:https://clinicaltrials.gov/ct2/show/NCT03106441.

Project description:BackgroundHigh-flow nasal cannula oxygen (HFNC) is a relatively new therapy used in adults with respiratory failure. Whether it is superior to conventional oxygen therapy (COT) or to noninvasive mechanical ventilation (NIV) remains unclear. The aim of the present study was to investigate whether HFNC was superior to either COT or NIV in adult acute respiratory failure patients.MethodsA review of the literature was conducted from the electronic databases from inception up to 20 October 2016. Only randomized clinical trials comparing HFNC with COT or HFNC with NIV were included. The intubation rate was the primary outcome; secondary outcomes included the mechanical ventilation rate, the rate of escalation of respiratory support and mortality.ResultsEleven studies that enrolled 3459 patients (HFNC, n?=?1681) were included. There were eight studies comparing HFNC with COT, two comparing HFNC with NIV, and one comparing all three. HFNC was associated with a significant reduction in intubation rate (OR 0.52, 95% CI 0.34 to 0.79, P?=?0.002), mechanical ventilation rate (OR 0.56, 95% CI 0.33 to 0.97, P?=?0.04) and the rate of escalation of respiratory support (OR 0.45, 95% CI 0.31 to 0.67, P?<?0.0001) when compared to COT. There was no difference in mortality between HFNC and COT utilization (OR 1.01, 95% CI 0.67 to 1.53, P?=?0.96). When HFNC was compared to NIV, there was no difference in the intubation rate (OR 0.96; 95% CI 0.66 to 1.39, P?=?0.84), the rate of escalation of respiratory support (OR 1.00, 95% CI 0.77 to 1.28, P?=?0.97) or mortality (OR 0.85, 95% CI 0.43 to 1.68, P?=?0.65).ConclusionsCompared to COT, HFNC reduced the rate of intubation, mechanical ventilation and the escalation of respiratory support. When compared to NIV, HFNC showed no better outcomes. Large-scale randomized controlled trials are necessary to prove our findings.Trial registrationPROSPERO International prospective register of systematic reviews on May 25, 2016 registration no. CRD42016039581 .

Project description:BACKGROUND:High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure. METHODS:COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa). RESULTS:Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of -?5.8% (95% CI, -?23.8-12.4%, p?=?0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of -?50.0% (95% CI, -?74.6 to -?12.9%, p?=?0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p?<?0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p?=?0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P?<?0.001] and [0 vs 9.6%, p?=?0.027], respectively. CONCLUSION:Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV. TRIAL REGISTRATION:chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.

Dataset Information

Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol.

Publications

Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol.

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