PRISM: prevention of respiratory insufficiency after surgical management

Prevention of Respiratory Insufficiency after Surgical Management (PRISM) Trial: a pragmatic randomised controlled trial of continuous positive airway pressure (CPAP) to prevent respiratory complications and improve survival following major abdominal surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56012545

Enrollment

4800

Registered

2016-02-04

Start date

2016-02-08

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Anaesthesia, perioperative medicine and pain management

Interventions

Following provision of informed consent, participants are randomly allocated to one of two groups using a computer generated dynamic procedure. Intervention group: Following surgery,

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
1. Pneumonia within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 2. Endotracheal re-intubation within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 3. Death within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 4. Postoperative infection within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 5. Mechanical ventilation (invasive or non-invasive), ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 6. All-cause mortality at one year after randomisation, ascertained by request hospital episode statistics and mortality data from the HSCIC for UK participants only. Prospective consent for ONS/HES data linkage will be sought before enrolment into the trial 7. Quality adjusted life years (QALY), ascertained by patient telephone interview using the EQ-5D(3L) questionnaire at one year after randomisation	—

Measure

Time frame

1. Pneumonia within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 2. Endotracheal re-intubation within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 3. Death within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 4. Postoperative infection within 30 days of randomisation, ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 5. Mechanical ventilation (invasive or non-invasive), ascertained through review of patient notes and by patient telephone interview within 30 days of randomisation 6. All-cause mortality at one year after randomisation, ascertained by request hospital episode statistics and mortality data from the HSCIC for UK participants only. Prospective consent for ONS/HES data linkage will be sought before enrolment into the trial 7. Quality adjusted life years (QALY), ascertained by patient telephone interview using the EQ-5D(3L) questionnaire at one year after randomisation

—

Countries

United Kingdom

Contacts

Public ContactMari-Liis Pakats

m.pakats@qmul.ac.uk+44 203 59 40352

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026