PRISM Trial

Not Applicable

Recruiting

• Conditions: Digestive System; Nutritional, Metabolic, Endocrine; Intra-peritoneal conditions

• Registration Number: PACTR201707002360211
• Lead Sponsor: Queen Mary Univeristy, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4800

Inclusion Criteria

Patients aged 50 years or over 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) Current 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 within 30 days of randomisation

Secondary Outcome Measures

Name	Time	Method
To determine whether routine postoperative CPAP reduces other forms of postoperative morbidity, mortality, or improves quality of life.