Randomised trial comparing advanced airway management during in-hospital cardiac arrest
- Conditions
- In-hospital cardiac arrest that requires advanced airway managementCirculatory 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
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
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
Name Time Method Functional status as measured by the modified Rankin Scale (mRS) at hospital discharge (or 30 days post-randomisation whichever is shorter)
- Secondary Outcome Measures
Name Time Method 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