Physiologic Effects of CPAP After Vascular Surgery (PhyCUS)

June 29, 2018 updated by: Paolo Pelosi, University of Genova
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • Policlinico San Martino
        • Sub-Investigator:
          • Lorenzo Ball, MD
        • Contact:
        • Principal Investigator:
          • Paolo Pelosi, Chief of ICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Major open vascular surgery
Surgical procedures on the abdominal aorta requiring median abdominal incision
Device: Postoperative preventive CPAP
Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2
Endovascular aortic repair
Abdominal aortic repair with endovascular approach
Device: Postoperative preventive CPAP
Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2/FIO2 ratio
Time Frame: Two hours after the administration of CPAP
Increase of the PaO2/FIO2 ratio compared to the baseline value
Two hours after the administration of CPAP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal pressure-time product (PTPes)
Time Frame: Two hours after the administration of CPAP
Increase of the PTPes compared to the baseline value
Two hours after the administration of CPAP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Genova

Investigators

  • Principal Investigator: Lorenzo Ball, MD, Universita degli Studi di Genova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2018

Primary Completion (Anticipated)

May 25, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhyCUS Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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