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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03543930
Other study ID # PhyCUS Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2018
Est. completion date July 1, 2019

Study information

Verified date June 2018
Source University of Genova
Contact Paolo Pelosi, Prof.
Phone +39 335 5941740?
Email ppelosi@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date July 1, 2019
Est. primary completion date May 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Postoperative preventive CPAP
Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2

Locations

Country Name City State
Italy Policlinico San Martino Genova

Sponsors (1)

Lead Sponsor Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary PaO2/FIO2 ratio Increase of the PaO2/FIO2 ratio compared to the baseline value Two hours after the administration of CPAP
Secondary Esophageal pressure-time product (PTPes) Increase of the PTPes compared to the baseline value Two hours after the administration of CPAP
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