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Physiologic Effects of CPAP After Vascular Surgery (PhyCUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543930
Recruitment Status : Unknown
Verified June 2018 by Paolo Pelosi, University of Genova.
Recruitment status was:  Recruiting
First Posted : June 1, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Pelosi, University of Genova

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Complications Respiratory Failure Device: Postoperative preventive CPAP

Study Design
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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Physiologic Effects of CPAP After Vascular Surgery
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : July 1, 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. PaO2/FIO2 ratio [ Time Frame: Two hours after the administration of CPAP ]
    Increase of the PaO2/FIO2 ratio compared to the baseline value


Secondary Outcome Measures :
  1. Esophageal pressure-time product (PTPes) [ Time Frame: Two hours after the administration of CPAP ]
    Increase of the PTPes compared to the baseline value


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543930


Contacts
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Contact: Paolo Pelosi, Prof. +39 335 5941740‬ ppelosi@hotmail.com

Locations
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Italy
Policlinico San Martino Recruiting
Genova, Italy, 16132
Contact: Paolo Pelosi, Professor    +39 010 5554970    ppelosi@hotmail.com   
Principal Investigator: Paolo Pelosi, Chief of ICU         
Sub-Investigator: Lorenzo Ball, MD         
Sponsors and Collaborators
University of Genova
Investigators
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Principal Investigator: Lorenzo Ball, MD Università degli Studi di Genova
More Information
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Responsible Party: Paolo Pelosi, Prof., University of Genova
ClinicalTrials.gov Identifier: NCT03543930    
Other Study ID Numbers: PhyCUS Study
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Postoperative Complications
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes