A2B – a study investigating the effect of different types of sedation on the length of time critically ill patients require ventilation in intensive care
- Conditions
- Critically ill intensive care patients receiving mechanical ventilationNot Applicable
- Registration Number
- ISRCTN18035454
- Lead Sponsor
- Academic and Clinical Central Office for Research and Development (ACCORD)
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38072483/ (added 30/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1437
Current participant inclusion criteria as of 22/06/2020:
1. Patient requiring mechanical ventilation (MV) in an ICU
2. Aged 18 years or over
3. Within 48 h of first episode of MV in ICU
4. Requiring sedation with propofol
5. Expected to require a total of 48 hours of MV or more in ICU
6. Expected to require a further 24 hours of MV or more at the time of randomisation in the opinion of the responsible clinician
_____
Previous inclusion criteria:
1. Patient requiring mechanical ventilation (MV) in an ICU
2. Aged 18 or over
3. Within 48 hours of starting MV in an ICU
4. Requiring sedation with propofol
5. Expected to require a total of 48 hours of MV or more in ICU
6. Expected to require a further 24 hours of MV or more at the time of randomisation in the opinion of the responsible clinician
Current exclusion criteria as of 22/06/2020:
1. Acute brain injury (traumatic brain injury; intracranial haemorrhage; ischaemic brain injury from stroke or hypoperfusion)
2. Post-cardiac arrest (where there is clinical concern about hypoxic brain injury)
3. Status epilepticus
4. Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
5. Guillain-Barre Syndrome
6. Myasthenia gravis
7. Home ventilation
8. Fulminant hepatic failure
9. Patient not expected to survive 24 h by responsible clinician
10. Decision to provide only palliative or end-of-life care
11. Pregnancy
12. Known allergy to one of the study drugs
13. Untreated second or third degree heart block
14. Transferred from another Intensive Care Unit in which MV occurred for >6 h
15. Prisoners
16. Enrolled on another CTIMP
17. Previously enrolled on the A2B Trial
18. Patients with bradycardia: a heart rate of <50 bpm for a period of 60 min or longer since starting MV in the ICU
Previous exclusion criteria:
1. Acute brain injury (traumatic brain injury; intracranial haemorrhage; ischaemic brain injury from stroke or hypoperfusion)
2. Post-cardiac arrest (where there is clinical concern about hypoxic brain injury)
3. Status epilepticus
4. Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
5. Guillain-Barre Syndrome
6. Myasthenia gravis
7. Home ventilation
8. Fulminant hepatic failure
9. Patient not expected to survive 24 hours by responsible clinician
10. Decision to provide only palliative or end-of-life care
11. Pregnancy
12. Known allergy to one of the study drugs
13. Untreated second or third degree heart block
14. Transferred from another Intensive Care Unit in which MV occurred for >6 hours
15. Prisoners
16. Enrolled on another CTIMP
17. Previously enrolled on the A2B Trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to successful extubation post-randomisation (hours). A successful first extubation from mechanical ventilation will be defined as follows:<br>1. From endotracheal extubation: time of first extubation that is followed by 48 hours of spontaneous breathing<br>2. From tracheostomy: time of extubation will be defined as the first time a patient receives support not exceeding 5 cmH2O CPAP with less or equal to pressure support ventilation of 5cmH2O for a continuous period of 48 hours<br><br>Added 30/07/2027:<br>3. From non-invasive mechanical ventilation (NIV): time of extubation will be the start time of the first period during which a patient receives support not exceeding 5 cmH2O CPAP via mask/hood for a continuous period of 48 hours. NIV patients receiving any pressure-supported breaths will not be considered to be spontaneously breathing unassisted. <br><br>Timepoints: Time of randomisation and time of successful extubation
- Secondary Outcome Measures
Name Time Method