Physiologic Effects of CPAP After Vascular Surgery

• Conditions: Postoperative Complications; Respiratory Failure
• Interventions: Device: Postoperative preventive CPAP

• Registration Number: NCT03543930
• Lead Sponsor: University of Genova

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study Start: 2018-05-25
• Status Verified: 2018-06
• Study First Posted: 2018-06-01
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-03
• Primary Completion: 2019-05-25
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Major open vascular surgery	Postoperative preventive CPAP	Surgical procedures on the abdominal aorta requiring median abdominal incision
Endovascular aortic repair	Postoperative preventive CPAP	Abdominal aortic repair with endovascular approach

Primary Outcome Measures

Name	Time	Method
PaO2/FIO2 ratio	Two hours after the administration of CPAP	Increase of the PaO2/FIO2 ratio compared to the baseline value

Secondary Outcome Measures

Name	Time	Method
Esophageal pressure-time product (PTPes)	Two hours after the administration of CPAP	Increase of the PTPes compared to the baseline value

Trial Locations

Locations (1)

Policlinico San Martino; 🇮🇹 Genova, Italy