PRISM: prevention of respiratory insufficiency after surgical management

Not Applicable

Completed

• Conditions: Topic: Anaesthesia, perioperative medicine and pain management; Subtopic: Anaesthesia, perioperative medicine and pain management; Disease: All Anaesthesia, perioperative medicine and pain management; Respiratory; Respiratory complications following surgery

• Registration Number: ISRCTN56012545
• Lead Sponsor: Barts & London School of Medicine

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27763576 2021 results in https://pubmed.ncbi.nlm.nih.gov/34153272/ (added 22/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-04
• Study Completion: 2019-12-15
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4806

Inclusion Criteria

1. Aged 50 years or over
2. Undergoing elective major intra-peritoneal surgery using an open surgical technique

Exclusion Criteria

1. Inability or refusal to provide informed consent
2. Anticipated requirement for invasive or non-invasive mechanical ventilation for at least four hours after surgery as part of routine care
3. Pregnancy or obstetric surgery
4. Previous enrollment in PRISM trial
5. Participation in a clinical trial of a treatment with a similar biological mechanism or related primary outcome measure
6. Clinician refusal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint of pneumonia, endotracheal re-intubation or death, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation