Dataset Information

Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN).

ABSTRACT:

Introduction

Heated, humidified, high-flow nasal cannula oxygen therapy has been used as a therapy for hypoxic respiratory failure in numerous clinical settings. To date, limited data exist to guide appropriate use following cardiac surgery, particularly among patients at risk for experiencing reintubation. We hypothesised that postextubation treatment with high-flow nasal cannula would decrease the all-cause reintubation rate within the 48 hours following initial extubation, compared with usual care.

Methods and analysis

Adult patients undergoing cardiac surgery (open surgery on the heart or thoracic aorta) will be automatically enrolled, randomised and allocated to one of two treatment arms in a pragmatic randomised controlled trial at the time of initial extubation. The two treatment arms are administration of heated, humidified, high-flow nasal cannula oxygen postextubation and usual care (treatment at the discretion of the treating provider). The primary outcome will be all-cause reintubation within 48 hours of initial extubation. Secondary outcomes include all-cause 30-day mortality, hospital length of stay, intensive care unit length of stay and ventilator-free days. Interaction analyses will be conducted to assess the differential impact of the intervention within strata of predicted risk of reintubation, calculated according to our previously published and validated prognostic model.

Ethics and dissemination

Vanderbilt University Medical Center IRB approval, 15 March 2021 with waiver of written informed consent. Plan for publication of study protocol prior to study completion, as well as publication of results.

Trial registration number

clinicaltrials.gov, NCT04782817 submitted 25 February 2021.

Date of protocol

29 August 2022. Version 2.0.

SUBMITTER: Freundlich RE

PROVIDER: S-EPMC9703331 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN).

Freundlich Robert E RE Wanderer Jonathan P JP French Benjamin B Moore Ryan P RP Hernandez Antonio A Shah Ashish S AS Byrne Daniel W DW Pandharipande Pratik P PP

BMJ open 20221125 11

<h4>Introduction</h4>Heated, humidified, high-flow nasal cannula oxygen therapy has been used as a therapy for hypoxic respiratory failure in numerous clinical settings. To date, limited data exist to guide appropriate use following cardiac surgery, particularly among patients at risk for experiencing reintubation. We hypothesised that postextubation treatment with high-flow nasal cannula would decrease the all-cause reintubation rate within the 48 hours following initial extubation, compared wi ...[more]

PMID: 36428016

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Project description:BackgroundHigh-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.MethodsWe 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.ResultsBetween 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).ConclusionsAmong 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.

Dataset Information

Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Date of protocol

Publications

Protocol for a randomised controlled trial: reducing reintubation among high-risk cardiac surgery patients with high-flow nasal cannula (I-CAN).

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