Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002360211 Date of Approval: 15/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title PRISM Trial
Official scientific title Prevention of Respiratory Insufficiency after Surgical Management (PRISM) Trial
Brief summary describing the background and objectives of the trial The lasting impact of postoperative morbidity should not be nderestimated, since complications following surgery are associated with reduced long-term survival (Khuri, Henderson et al. 2005, Head, Ferrie et al. 2008). Some of the most common postoperative complications affect the respiratory tract (Warner 2000). The published incidence of postoperative pulmonary complications ranges from 9 to 40%, depending on the definition used (Arozullah, Daley et al. 2000, Ireland, Chapman et al. 2014). Major abdominal surgery is associated with adverse changes in respiratory function. Anaesthesia can cause reduced vital capacity, hypoxaemia and impaired central respiratory drive, while surgical manipulation can restrict ventilation, damage the respiratory muscles and cause atelectasis (Nunn and Payne 1962). Continuous positive airway pressure (CPAP) is a non-invasive method of supporting respiratory function. The findings of several trials have demonstrated the efficacy of CPAP as a preventative treatment for high-risk patients following abdominal surgery by reducing the incidence postoperative pulmonary complications. There is a clear need for a major randomised trial to provide definitive evidence to address this uncertainty. The Prism trial is a large, pragmatic, international multi-centre trial, to confirm the clinical effectiveness of CPAP administered as routine for four hours immediately following major abdominal surgery, compared to usual clinical care. Eligible patients are aged 50 years and over, undergoing major elective intra-peritoneal surgery. The trial intervention is defined as CPAP for at least four hours, with minimal interruption, started immediately after (within four hours after) the end of surgery. The primary outcome measure is a composite of pneumonia, re-intubation, or death within 30 days of randomisation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not applicable
Disease(s) or condition(s) being studied Digestive System,Intra-peritoneal conditions ,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/06/2017
Actual trial start date 19/06/2017
Anticipated date of last follow up 21/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 4800
Actual target sample size (number of participants) 400
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Participants will be centrally allocated to treatment groups (1:1) by a computer generated dynamic procedure (minimisation) with a random component. Minimisation variables will be country, surgical procedure category and planned use of epidural anaesthesia. Simple randomisation using a radomisation table created by a computer software program Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Continous positive airway pressure (CPAP) One CPAP fitted postoperatively 4 Hours postoperatively Continous positive airway pressure 2400 Active-Treatment of Control Group
Control Group Standard care Not applicable Not applicable Standard routine postoperative care 2400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 50 years or over undergoing elective major intra-peritoneal surgery using an open surgical technique. 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 50 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/02/2017 UCT Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road, Observatory Cape Town 7599 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Composite endpoint of pneumonia, endotracheal re-intubation or death within 30 days of randomisation Within 30 days of randomisation
Secondary Outcome To determine whether routine postoperative CPAP reduces other forms of postoperative morbidity, mortality, or improves quality of life. Within 30 days of randomisation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Anzio Road, Observatory Cape Town 7599 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Queen Mary Univeristy, London 5 Walden Street London E1 2EF United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Queen Mary Univeristy, London 5 Walden Street London E1 2EF United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Queen Mary Univeristy, London 5 Walden Street London E1 2EF United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Margot Flint margot.flint@uct.ac.za 0721222111 D23, Department of Anaesthesia, New Groote Schuur Hospital
City Postal code Country Position/Affiliation
0218988567 7925 South Africa Chief Scientific Officer
Role Name Email Phone Street address
Principal Investigator Rowan Duys rowanduys@gmail.com 0214045001 Anzio Road, Observatory
City Postal code Country Position/Affiliation
7599 South Africa Consultant Anaethetist
Role Name Email Phone Street address
Public Enquiries Margot Flint margot.flint@uct.ac.za 0721222111 D23, Department of Anaesthesia, New Groote Schuur Hospital, Main Road
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Chief Scientific Officer
Role Name Email Phone Street address
Public Enquiries Rowan Duys rowanduys@gmail.com 0214045001 D23, Department of Anaesthesia, New Groote Schuur Hospital, Main Road
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Consultant
Role Name Email Phone Street address
Scientific Enquiries Margot Flint margot.flint@uct.ac.za 0721222111 D23, Department of Anaesthesia, New Groote Schuur Hospital, Main Road
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Chief Scientific Officer
REPORTING
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