Physiologic Effects of CPAP After Vascular Surgery

Postoperative Complications Clinical Trial

— PhyCUS  

Official title:

Physiologic Effects of CPAP After Vascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543930
• Other study ID #: PhyCUS Study
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Postoperative Complications
• Respiratory Failure
• Respiratory Insufficiency

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