Physiologic Effects of CPAP After Vascular Surgery

NCT ID: NCT03543930

Last Updated: 2018-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-07-01

Brief Summary

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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

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Conditions

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Postoperative Complications Respiratory Failure

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Major open vascular surgery

Surgical procedures on the abdominal aorta requiring median abdominal incision

Postoperative preventive CPAP

Intervention Type DEVICE

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

Postoperative preventive CPAP

Intervention Type DEVICE

Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2

Interventions

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Postoperative preventive CPAP

Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Genova

OTHER

Sponsor Role lead

Responsible Party

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Paolo Pelosi

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenzo Ball, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Genova

Locations

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Policlinico San Martino

Genova, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Pelosi, Prof.

Role: CONTACT

+39 335 5941740‬

Facility Contacts

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Paolo Pelosi, Professor

Role: primary

+39 010 5554970

Other Identifiers

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PhyCUS Study

Identifier Type: -

Identifier Source: org_study_id

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