Status:
UNKNOWN
Abdominal Pressure Assessment Following Open Abdominal Surgery
Lead Sponsor:
University Magna Graecia
Conditions:
Lung Collapse
Eligibility:
All Genders
50+ years
Brief Summary
During abdominal surgery, the intra abdominal pressure may increase determining lung bibasal atelectasis. The investigators hypothesized that the application of Positive End Expiratory Pressure (PEEP)...
Detailed Description
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 man...
Eligibility Criteria
Inclusion
- Patients aged 50 years or over undergoing major, open, intra-peritoneal surgery, randomized to receive Continuous Positive Airway Pressure in the "Prevention of Respiratory Insufficiency after Surgical Management (P.R.I.S.M. TRIAL)"
Exclusion
- Inability or refusal to provide informed consent
- Anticipated requirement for invasive or non-invasive mechanical ventilation for at least four hours after surgery as part of routine care
- Pregnancy or obstetric surgery
- Previous enrollment in PRISM trial
- Participation in a clinical trial of a treatment with a similar biological mechanism or related primary outcome measure
- Clinician refusal
Key Trial Info
Start Date :
March 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03369483
Start Date
March 13 2018
End Date
March 31 2021
Last Update
November 5 2020
Active Locations (5)
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1
Magna Graecia University - University Hospital Mater Domini
Catanzaro, Italy
2
Dipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Sezione di Anestesiologia e Terapia Intensiva Universitaria, Università degli studi di Ferrara
Ferrara, Italy
3
Department of Anesthesia and Intensive Care, IRCCS Policlinic San Matteo Hospital Foundation , Pavia , Italy
Pavia, Italy
4
Anesthesia and Intensive Care Medicine, Sapienza University of Rome, Policlinico Umberto I Hospital
Roma, Italy