Physiologic Effects of CPAP After Vascular Surgery
PhyCUS
1 other identifier
observational
18
1 country
1
Brief Summary
This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedStudy Start
First participant enrolled
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 3, 2018
June 1, 2018
1 year
May 18, 2018
June 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
PaO2/FIO2 ratio
Increase of the PaO2/FIO2 ratio compared to the baseline value
Two hours after the administration of CPAP
Secondary Outcomes (1)
Esophageal pressure-time product (PTPes)
Two hours after the administration of CPAP
Study Arms (2)
Major open vascular surgery
Surgical procedures on the abdominal aorta requiring median abdominal incision
Endovascular aortic repair
Abdominal aortic repair with endovascular approach
Interventions
Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2
Eligibility Criteria
Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach
You may qualify if:
- Open or endovascular surgery on the abdominal aorta
- Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
- Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)
You may not qualify if:
- Prolonged post-operative invasive ventilation
- Invasive or non-invasive ventilation or oxygen therapy in the last month
- ASA class IV or V
- Emergency procedures
- Pneumothorax or active pulmonary infection
- Any contraindication to CPAP
- Prolonged bed rest
- Patient refusal to participate or to receive preventive CPAP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico San Martino
Genova, 16132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Ball, MD
Università degli Studi di Genova
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 18, 2018
First Posted
June 1, 2018
Study Start
May 25, 2018
Primary Completion
May 25, 2019
Study Completion
July 1, 2019
Last Updated
July 3, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share