scholarly journals High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e023772 ◽  
Author(s):  
Arnaud W Thille ◽  
Grégoire Muller ◽  
Arnaud Gacouin ◽  
Rémi Coudroy ◽  
Alexandre Demoule ◽  
...  

IntroductionRecent practice guidelines suggest applying non-invasive ventilation (NIV) to prevent postextubation respiratory failure in patients at high risk of extubation failure in intensive care unit (ICU). However, such prophylactic NIV has been only a conditional recommendation given the low certainty of evidence. Likewise, high-flow nasal cannula (HFNC) oxygen therapy has been shown to reduce reintubation rates as compared with standard oxygen and to be as efficient as NIV in patients at high risk. Whereas HFNC may be considered as an optimal therapy during the postextubation period, HFNC associated with NIV could be an additional means of preventing postextubation respiratory failure. We are hypothesising that treatment associating NIV with HFNC between NIV sessions may be more effective than HFNC alone and may reduce the reintubation rate in patients at high risk.Methods and analysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing HFNC alone or with NIV sessions during the postextubation period in patients at high risk of extubation failure in the ICU. Six hundred patients will be randomised with a 1:1 ratio in two groups according to the strategy of oxygenation after extubation. The primary outcome is the reintubation rate within the 7 days following planned extubation. Secondary outcomes include the number of patients who meet the criteria for moderate/severe respiratory failure, ICU length of stay and mortality up to day 90.Ethics and disseminationThe study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03121482.

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018611 ◽  
Author(s):  
Jean-Pierre Frat ◽  
Jean-Damien Ricard ◽  
Rémi Coudroy ◽  
René Robert ◽  
Stéphanie Ragot ◽  
...  

IntroductionEndotracheal 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.Methods and analysisThe 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.Ethics and disseminationThe 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.Trial registration numberNCT02668458; Pre-results.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e045659
Author(s):  
René Robert ◽  
Denis Frasca ◽  
Julie Badin ◽  
C Girault ◽  
Christophe Guitton ◽  
...  

IntroductionA palliative approach to intensive care unit (ICU) patients with acute respiratory failure and a do-not-intubate order corresponds to a poorly evaluated target for non-invasive oxygenation treatments. Survival alone should not be the only target; it also matters to avoid discomfort and to restore the patient’s quality of life. We aim to conduct a prospective multicentre observational study to analyse clinical practices and their impact on outcomes of palliative high-flow nasal oxygen therapy (HFOT) and non-invasive ventilation (NIV) in ICU patients with do-not-intubate orders.Methods and analysisThis is an investigator-initiated, multicentre prospective observational cohort study comparing the three following strategies of oxygenation: HFOT alone, NIV alternating with HFOT and NIV alternating with standard oxygen in patients admitted in the ICU for acute respiratory failure with a do-not-intubate order. The primary outcome is the hospital survival within 14 days after ICU admission in patients weaned from NIV and HFOT. The sample size was estimated at a minimum of 330 patients divided into three groups according to the oxygenation strategy applied. The analysis takes into account confounding factors by modelling a propensity score.Ethics and disseminationThe study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03673631


2021 ◽  
Vol 18 (1) ◽  
pp. 47-56
Author(s):  
К. A. Tsygankov ◽  
I. N. Grachev ◽  
Vladimir I. Shatalov ◽  
А. V. Schegolev ◽  
D. A. Аveryanov ◽  
...  

The objective: to evaluate the effect of high-flow oxygen and non-invasive ventilation on the mortality rate in adults with severe respiratory failure caused by the new coronavirus infection in the intensive care unit (ICU).Subjects and methods. A one-center retrospective study was conducted. Electronic medical files of patients treated in the ICU from April 1 to May 25, 2020, were analyzed. Totally, 101 medical files were selected, further, they were divided into two groups. Group 1 (n = 49) included patients who received oxygen insufflation, and should it fail, they received traditional artificial ventilation. No non-invasive respiratory therapy was used in this group. Group 2 (n = 52) included patients who received high-flow oxygen therapy and non-invasive ventilation. The mortality rate in the groups made a primary endpoint for assessing the impact of high-flow oxygen therapy and non-invasive ventilation. The following parameters were also analyzed: drug therapy, the number of patients in whom non-invasive techniques were used taking into account the frequency of cases when these techniques failed, and the number of patients in whom artificial ventilation was initiated.Results. In Group 2, non-invasive methods of respiratory therapy were used in 31 (60%) cases. High-flow oxygen therapy was used in 19 (36%) of them; in 13 cases this method allowed weaning them from the high flow. Non-invasive ventilation was used in 18 cases, in 12 patients it was used due to progressing severe respiratory failure during humidified oxygen insufflation, in 6 patients – after the failed high-flow oxygen therapy. In Group 1, 25 (51%) patients were intubated and transferred to artificial ventilation, in Group 2, 10 (19.2%) underwent the same. The lethal outcome was registered in 23 (47%) cases in Group 1, and in 10 (19.2%) in Group 2 (p = 0.004). Analysis of drug therapy in the groups revealed the difference in the prescription of pathogenetic therapy. Logistic regression demonstrated the effectiveness of the combination of tocilizumab + a glucocorticoid in reducing the frequency of lethal cases (p = 0.001).Conclusion. The use of non-invasive respiratory support in adults with severe respiratory failure caused by the new coronavirus infection combined with therapy by tocilizumab + a glucocorticoid can reduce the incidence of lethal cases.


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