Condition category
Respiratory
Date applied
03/02/2016
Date assigned
04/02/2016
Last edited
24/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Surgical complications are a major healthcare problem. Every year, around 310 million operations are carried out worldwide. After surgery more than 50 million patients will develop complications with more than three million deaths. The risk of illness or death following surgery is greatest for patients who have pre-existing medical conditions, are elderly or are undergoing surgery where the abdomen needs to be opened by the surgeon. Breathing problems, such as partial collapse of the lung and pneumonia, can be caused by the combination of surgery and anaesthesia, which in turn may lead to life threatening respiratory failure. Recent studies have shown that a type of oxygen delivery called continuous positive airway pressure (CPAP), where the lungs are kept inflated with a continuous supply of air (with extra oxygen) at a mild pressure, can help to reduce the number of serious breathing problems after abdominal surgery. The aim of the PRISM trial is to find out whether CPAP used for four hours immediately after surgery can help to reduce respiratory complications and increase 30 day and one-year survival rates compared to usual care in patients undergoing major abdominal surgery.

Who can participate?
Adults aged 50 years or over who are having open abdominal surgery by choice (elective).

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive the CPAP treatment for four hours immediately after surgery. This involves wearing a tight facemask or clear hood (helmet) that delivers a continuous supply of oxygen. The mask is attached to a pump which provides a flow of air in order to keep the airways open. Participants in the second group receive usual treatment, which may involve wearing a standard, looser fitting face-mask to provide oxygen after surgery. One month and then again one year after surgery all participants are contacted by telephone in order to find out about their recovery. Patient notes are also reviewed at this time in order to find out about the length of their hospital stay and details about any complications they may have had following surgery.

What are the possible benefits and risks of participating?
The risks of this trial to health are very small. CPAP is very safe, and has been used in hospitals for many years. Some patients even use this at home to help them sleep. Occasionally people using CPAP can find the mask or hood uncomfortable, but small early studies suggest that CPAP should benefit most patients in this trial.

Where is the study run from?
The Royal London Hospital (UK), Sapienza University of Rome and University of Sassari (Italy)

When is the study starting and how long is it expected to run for?
May 2015 to December 2019

Who is funding the study?
1. National Institute for Health Research (UK)
2. Intersurgical Ltd (UK)
3. National Institute for Academic Anaesthesia (UK)

Who is the main contact?
Mr Richard Haslop
r.haslop@qmul.ac.uk

Trial website

prismtrial.org

Contact information

Type

Public

Primary contact

Mr Richard Haslop

ORCID ID

Contact details

Adult Critical Care Research
Room 14
Central Tower
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20252

Study information

Scientific title

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

Acronym

PRISM

Study hypothesis

The aim of this study is to determine whether early postoperative CPAP reduces the incidence of respiratory complications and improves one-year survival following major intra-peritoneal surgery.

Ethics approval

London - Central Research Ethics Committee, 02/10/2015, ref: 15/LO/1595

Study design

International multi-centre randomised controlled trial with open study group allocation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Anaesthesia, perioperative medicine and pain management; Subtopic: Anaesthesia, perioperative medicine and pain management; Disease: All Anaesthesia, perioperative medicine and pain management

Intervention

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

Intervention group: Following surgery, participants receive the continuous positive airway pressure (CPAP) intervention for at least four hours, after which the CPAP will be continued or discontinued at the clinician’s discretion. The CPAP involves breathing through a pressurized circuit against a threshold resistor that maintains a pre-set positive airway pressure during both inspiration and expiration, through a face-mask, helmet or nasal device.

Control group: Following surgery, participants will receive usual care, managed by clinical staff according to local policy and guidelines.

Participants are followed up through medical record (paper or electronic) review and brief telephone interviews at 30 days and one year after surgery.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/05/2014

Overall trial end date

15/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 4800; UK Sample Size: 2400; Description: The total sample size will be 4800 patients, recruited from several EU countries.

Participant 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

Recruitment start date

08/02/2016

Recruitment end date

15/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Trial participating centre

Sapienza University of Rome (Sapienza Universita di Roma)
Piazzale Aldo Moro, 5,
Roma
00185
Italy

Trial participating centre

University of Sassari (Università degli Studi di Sassari)
Piazza d'Armi, 17
Sassari SS
07100
Italy

Sponsor information

Organisation

Barts & London School of Medicine

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Intersurgical Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Academic Anaesthesia

Alternative name(s)

NIAA

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal, conference presentations and webcasts. We intend to publish the main paper as soon as possible after completion of the trial.

Intention to publish date

15/12/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27763576

Publication citations

Additional files

Editorial Notes

24/10/2016: added pub. 26/02/2016: Recruitment start date changed from 15/12/2015 to 08/02/2016.