Dataset Information

High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial.

ABSTRACT:

Introduction

Acute respiratory failure is a common clinical condition accounting for nearly 116?000 admissions in the UK hospitals. Acute type 2 respiratory failure is also called acute hypercapnic respiratory failure (AHRF) and characterised by an elevated arterial CO₂ level of >6?kPa due to pump failure. Acute exacerbation of chronic obstructive pulmonary disease is the most common cause of AHRF. High-flow nasal therapy (HFNT) is a new oxygen delivery system that uses an oxygen-air blender to deliver flow rates of up to 60?L/min. The gas is delivered humidified and heated to the patient via wide-bore nasal cannula.

Methods and analysis

We hypothesised that HFNC as the initial oxygen administration method will reduce the number of patients with AHRF requiring non-invasive ventilation in patients at 6?hours post intervention when compared with low-flow nasal oxygen (LFO). A randomised single-centre unblinded controlled trial is designed to test our hypothesis. The trial will compare two oxygen administration methods, HFNT versus LFO. Patients will be randomised to one of the two arms if they fulfil the eligibility criteria. The sample size is 82 adult patients (41 HFNT and 41 LFO) presenting to the emergency department.

Ethics and dissemination

Ethical approval was obtained from the Office for Research Ethics Committees Northern Ireland (REC reference: 20/NI/0049). Dissemination will be achieved in several ways: (1) the findings will be presented at national and international meetings with open-access abstracts online and (2) in accordance with the open-access policies proposed by the leading research funding bodies we aim to publish the findings in high-quality peer-reviewed open-access journals.

Trial registration number

The trial was prospectively registered at the clinicaltrials.gov registry (NCT04640948) on 20 November 2020.

SUBMITTER: Alnajada A

PROVIDER: S-EPMC7798411 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial.

Alnajada Asem A Blackwood Bronagh B Mobrad Abdulmajeed A Akhtar Adeel A Shyamsundar Murali M

BMJ open respiratory research 20210101 1

<h4>Introduction</h4>Acute respiratory failure is a common clinical condition accounting for nearly 116 000 admissions in the UK hospitals. Acute type 2 respiratory failure is also called acute hypercapnic respiratory failure (AHRF) and characterised by an elevated arterial CO<sub>2</sub> level of >6 kPa due to pump failure. Acute exacerbation of chronic obstructive pulmonary disease is the most common cause of AHRF. High-flow nasal therapy (HFNT) is a new oxygen delivery system that uses an oxy ...[more]

PMID: 33419742

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Project description:Background:Although the efficacy and safety of high-flow nasal cannula (HFNC) in hypoxemic respiratory failure are widely recognized, it is yet unclear whether HFNC can effectively reduce the intubation rate and mortality in hypercapnic respiratory failure. We performed a systematic review and meta-analysis to assess the safety and efficiency of HFNC in these patients. Methods:A systematic search of PubMed, Embase, and Cochrane Library (CENTRAL) was carried out. Two reviewers independently screened all references according to the inclusion criteria. We used the Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale to assess the quality of randomized controlled trials (RCTs) and cohort studies, respectively. Data from eligible trials were extracted for the meta-analysis. Results:Eight studies with a total of 621 participants were included (six RCTs and two cohort studies). Our analysis showed that HFNC is noninferior to noninvasive ventilation (NIV) with respect to intubation rate in both RCTs (OR?=?0.92, 95% CI: 0.45-1.88) and cohort studies (OR?=?0.94, 95% CI: 0.55-1.62). Similarly, the analysis of cohort studies showed no difference in reducing mortality rates (OR?=?0.96, 95% CI: 0.42-2.20). Based on RCTs, NIV seemed more effective in reducing mortality (OR?=?1.33, 95% CI: 0.68-2.60), but the intertreatment difference was not statistically signi?cant. Furthermore, no significant differences were found between HFNC and NIV relating to change of blood gas analysis or respiratory rate (MD?=?-0.75, 95% CI: -2.6 to 1.09). Likewise, no significant intergroup differences were found with regard to intensive care unit stay (SMD?=?-0.07, 95% CI: 0.26 to 0.11). Due to a physiological friendly interface and variation, HFNC showed a significant advantage over NIV in patients' comfort and complication of therapy. Conclusion:Despite the limitations noted, HFNC may be an effective and safe alternative to prevent endotracheal intubation and mortality when NIV is unsuitable in mild-to-moderate hypercapnia. Further high-quality studies are needed to validate these findings.

Project description:Rationale: The long-term effects of using a high-flow nasal cannula for chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease remain unclear. Objectives: To assess whether long-term high-flow nasal cannula use reduces the number of exacerbations and improves other physiological parameters in patients with chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease. Methods: We enrolled 104 participants (aged ⩾40 yr) with daytime hypercapnia (Global Initiative for Chronic Obstructive Lung Disease stages 2-4) receiving long-term oxygen therapy (⩾16 h/d for ⩾1 mo) and randomly assigned them to high-flow nasal cannula/long-term oxygen therapy and long-term oxygen therapy groups. The primary endpoint was the moderate or severe exacerbation rate. We compared changes from baseline in arterial blood gas values, peripheral oxygen saturation, pulmonary function, health-related quality-of-life scores, and the 6-minute-walk test. Measurements and Main Results: High-flow nasal cannula use significantly reduced the rate of moderate/severe exacerbations (unadjusted mean count 1.0 vs. 2.5, a ratio of the adjusted mean count between groups [95% confidence interval] of 2.85 [1.48-5.47]) and prolonged the duration without moderate or severe exacerbations. The median time to first moderate or severe exacerbation in the long-term oxygen therapy group was 25 (14.1-47.4) weeks; this was not reached in the high-flow nasal cannula/long-term oxygen therapy group. High-flow nasal cannula use significantly improved health-related quality of life scores, peripheral oxygen saturation, and specific pulmonary function parameters. No safety concerns were identified. Conclusions: A high-flow nasal cannula is a reasonable therapeutic option for patients with stable hypercapnic chronic obstructive pulmonary disease and a history of exacerbations. Clinical trial registered with www.umin/ac.jp (UMIN000028581) and www.clinicaltrials.gov (NCT03282019).

Project description:BackgroundHigh-flow nasal oxygen therapy (HFNC) may be an attractive first-line ventilatory support in COVID-19 patients. However, HNFC use for the management of COVID-19 patients and risk factors for HFNC failure remain to be determined.MethodsIn this retrospective study, we included all consecutive COVID-19 patients admitted to our intensive care unit (ICU) in the first (Mars-May 2020) and second (August 2020- February 202) French pandemic waves. Patients with limitations for intubation were excluded. HFNC failure was defined as the need for intubation after ICU admission. The impact of HFNC use was analyzed in the whole cohort and after constructing a propensity score. Risk factors for HNFC failure were identified through a landmark time-dependent cause-specific Cox model. The ability of the 6-h ROX index to detect HFNC failure was assessed by generating receiver operating characteristic (ROC) curve.Results200 patients were included: HFNC was used in 114(57%) patients, non-invasive ventilation in 25(12%) patients and 145(72%) patients were intubated with a median delay of 0 (0-2) days after ICU admission. Overall, 78(68%) patients had HFNC failure. Patients with HFNC failure had a higher ICU mortality rate (34 vs. 11%, p = 0.02) than those without. At landmark time of 48 and 72 h, SAPS-2 score, extent of CT-Scan abnormalities > 75% and HFNC duration (cause specific hazard ratio (CSH) = 0.11, 95% CI (0.04-0.28), per + 1 day, p < 0.001 at 48 h and CSH = 0.06, 95% CI (0.02-0.23), per + 1 day, p < 0.001 at 72 h) were associated with HFNC failure. The 6-h ROX index was lower in patients with HFNC failure but could not reliably predicted HFNC failure with an area under ROC curve of 0.65 (95% CI(0.52-0.78), p = 0.02). In the matched cohort, HFNC use was associated with a lower risk of intubation (CSH = 0.32, 95% CI (0.19-0.57), p < 0.001).ConclusionsIn critically-ill COVID-19 patients, while HFNC use as first-line ventilatory support was associated with a lower risk of intubation, more than half of patients had HFNC failure. Risk factors for HFNC failure were SAPS-2 score and extent of CT-Scan abnormalities > 75%. The risk of HFNC failure could not be predicted by the 6-h ROX index but decreased after a 48-h HFNC duration.

Dataset Information

High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial.

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