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Randomised trial comparing advanced airway management during in-hospital cardiac arrest

Not Applicable
Conditions
In-hospital cardiac arrest that requires advanced airway management
Circulatory System
Registration Number
ISRCTN17720457
Lead Sponsor
niversity Hospitals Bristol and Weston NHS Foundation Trust
Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37519411/ Protocol, design and implementation (added 31/07/2023)

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
4190
Inclusion Criteria

1. Adult (known or believed to be age =18 years)
2. In-hospital cardiac arrest, attended by the hospital cardiac arrest team in response to a cardiac arrest call (2222 or equivalent), and including a clinician permitted to undertake tracheal intubation and supraglottic airway placement so that either intervention can be delivered
3. Undergoing resuscitation and requiring advanced airway management in the opinion of the clinician managing the patient’s airway

Exclusion Criteria

Current exclusion criteria as of 02/08/2024:

1. Patients who have a cardiac arrest outside hospital and who are transported to the hospital in ongoing cardiac arrest
2. People who are not a hospital inpatient (e.g. visitor, relative, staff or outpatient)
3. Patients already receiving advanced airway management (including a supraglottic airway device) at the time of eligibility assessment
4. Patients known to be pregnant
5. Patients with a functioning tracheostomy

_____

Previous exclusion criteria:

1. Patients in the emergency department
2. People who are not a hospital inpatient (e.g. visitor, relative, staff or outpatient)
3. Patients already receiving advanced airway management (including a supraglottic airway device) at the time of eligibility assessment
4. Patients known to be pregnant
5. Patients with a functioning tracheostomy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional status as measured by the modified Rankin Scale (mRS) at hospital discharge (or 30 days post-randomisation whichever is shorter)
Secondary Outcome Measures
NameTimeMethod
1. Initial ventilation success measured using data collected from site staff into a bespoke application at baseline <br>2. Regurgitation/aspiration during resuscitation measured using data collected from site staff into a bespoke application at baseline <br>3. Return of spontaneous circulation (ROSC) >20 minutes measured using data collected from site staff into a bespoke application at baseline <br>4. ICU and hospital length of stay measured using data linkage from National Cardiac Arrest Audit (NCAA) at hospital discharge <br>5. Health-related quality of life measured using EQ5D-5L questionnaire at discharge, 3 and 6 months<br>6. Survival to hospital discharge, 3 months and 6 months measured using data linkage from NCAA and Office for National Statistics (ONS) death registry <br>7. Functional status (mRS) measured using the modified Rankin Scale (mRS) at 3 and 6 months
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