High flow in children with respiratory failure: A randomised controlled pilot trial – A paediatric acute respiratory intervention study

ObjectivesTo determine the feasibility of a large-scale definitive multicentre trial of prehospital continuous positive airway pressure (CPAP) in acute respiratory failure.DesignA single-centre, open-label, individual patient randomised, controlled, external pilot trial.SettingA single UK Ambulance Service, between August 2017 and July 2018.ParticipantsAdults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels despite controlled oxygen treatment.InterventionsPatients were randomised to prehospital CPAP (O-Two system) versus standard oxygen therapy in a 1:1 ratio using simple randomisation.Primary and secondary outcome measuresFeasibility outcomes comprised recruitment rate, adherence to allocated treatment, retention and data completeness. The primary clinical outcome was 30-day mortality.Results77 patients were enrolled (target 120), including 7 cases with a diagnosis where CPAP could be ineffective or harmful. CPAP was fully delivered in 74% (target 75%). There were no major protocol violations. Full data were available for all key outcomes (targets ≥90%). Overall 30-day mortality was 27.3%. Of these deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital non-invasive ventilation and critical care.ConclusionsRecruitment rate was below target and feasibility was not demonstrated. Limited compliance with CPAP, and difficulty in identifying patients who could benefit from CPAP, indicate that prehospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP is therefore not recommended.Trial registration numberISRCTN12048261; Post-results.

Download Full-text

Effect of high-flow nasal therapy during exercise training in COPD patients with chronic respiratory failure: study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-019-3440-2 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Michele Vitacca ◽

◽

Irene Pietta ◽

Marta Lazzeri ◽

Mara Paneroni

Keyword(s):

Respiratory Failure ◽

Randomised Controlled Trial ◽

Exercise Training ◽

Study Protocol ◽

Controlled Trial ◽

High Flow ◽

Chronic Respiratory Failure ◽

Copd Patients ◽

Randomised Controlled

Download Full-text

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

BMJ Open ◽

10.1136/bmjopen-2017-018611 ◽

2017 ◽

Vol 7 (12) ◽

pp. e018611 ◽

Cited By ~ 11

Author(s):

Jean-Pierre Frat ◽

Jean-Damien Ricard ◽

Rémi Coudroy ◽

René Robert ◽

Stéphanie Ragot ◽

...

Keyword(s):

Respiratory Failure ◽

Oxygen Therapy ◽

Ethics Committee ◽

High Flow ◽

Oxygen Desaturation ◽

Invasive Ventilation ◽

High Flow Nasal Cannula ◽

Non Invasive ◽

Non Invasive Ventilation ◽

Randomised Controlled

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.

Download Full-text

High-flow nasal oxygen cannula vs. noninvasive mechanical ventilation to prevent reintubation in sepsis: a randomized controlled trial

Annals of Intensive Care ◽

10.1186/s13613-021-00922-5 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Surat Tongyoo ◽

Porntipa Tantibundit ◽

Kiattichai Daorattanachai ◽

Tanuwong Viarasilpa ◽

Chairat Permpikul ◽

...

Keyword(s):

Mechanical Ventilation ◽

Respiratory Failure ◽

Primary Outcome ◽

Controlled Trial ◽

Spontaneous Breathing Trial ◽

High Flow ◽

Noninvasive Mechanical Ventilation ◽

Clinical Trial Registration ◽

Significant Difference ◽

Randomised Controlled

Abstract Background High-flow nasal oxygen cannula (HFNC) and noninvasive mechanical ventilation (NIV) can prevent reintubation in critically ill patients. However, their efficacy in post-extubated sepsis patients remains unclear. The objective of this study was to compare the efficacy of HFNC vs. NIV to prevent reintubation in post-extubated sepsis patients. Methods We conducted a single-centre, prospective, open-labelled, randomised controlled trial at the medical intensive care unit of Siriraj Hospital, Mahidol University, Bangkok, Thailand. Sepsis patients who had been intubated, recovered, and passed the spontaneous breathing trial were enrolled and randomly assigned in a 1:1 ratio to receive either HFNC or NIV support immediately after extubation. The primary outcome was rate of reintubation at 72 h after extubation. Results Between 1st October 2017 and 31st October 2019, 222 patients were enrolled and 112 were assigned to the HFNC group and 110 to the NIV group. Both groups were well matched in baseline characteristics. The median [IQR] age of the HFNC group was 66 [50–77] vs. 65.5 [54–77] years in the NIV group. The most common causes of intubation at admission were shock-related respiratory failure (57.1% vs. 55.5%) and acute hypoxic respiratory failure (34.8% vs. 40.9%) in the HFNC and NIV groups, respectively. The duration of mechanical ventilation before extubation was 5 [3–8] days in the HFNC group vs. 5 [3–9] days in the NIV group. There was no statistically significant difference in the primary outcome: 20/112 (17.9%) in the HFNC group required reintubation at 72 h compared to 20/110 (18.2%) in the NIV group [relative risk (RR) 0.99: 95% confidence interval (CI) (0.70–1.39); P = 0.95]. The 28-day mortality was not different: 8/112 (7.1%) with HFNC vs. 10/110 (9.1%) with NIV (RR 0.88: 95% CI (0.57–1.37); P = 0.59). Conclusions Among sepsis patients, there was no difference between HFNC and NIV in the prevention of reintubation at 72 h after extubation. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT03246893; Registered 11 August 2017; https://clinicaltrials.gov/ct2/show/NCT03246893?term=surat+tongyoo&draw=2&rank=3

Download Full-text

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 ◽

10.1136/bmjopen-2018-023772 ◽

2018 ◽

Vol 8 (9) ◽

pp. e023772 ◽

Cited By ~ 3

Author(s):

Arnaud W Thille ◽

Grégoire Muller ◽

Arnaud Gacouin ◽

Rémi Coudroy ◽

Alexandre Demoule ◽

...

Keyword(s):

Respiratory Failure ◽

High Risk ◽

Oxygen Therapy ◽

Extubation Failure ◽

High Flow ◽

Invasive Ventilation ◽

High Flow Nasal Cannula ◽

Non Invasive ◽

Non Invasive Ventilation ◽

Randomised Controlled

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.

Download Full-text