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Physiologic Effects of CPAP After Vascular Surgery

Physiologic Effects of CPAP After Vascular Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03543930
Acronym
PhyCUS
Enrollment
18
Registered
2018-06-01
Start date
2018-05-25
Completion date
2019-07-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Respiratory Failure

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.

Interventions

DEVICEPostoperative preventive CPAP

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

Sponsors

University of Genova
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PaO2/FIO2 ratioTwo hours after the administration of CPAPIncrease of the PaO2/FIO2 ratio compared to the baseline value

Secondary

MeasureTime frameDescription
Esophageal pressure-time product (PTPes)Two hours after the administration of CPAPIncrease of the PTPes compared to the baseline value

Countries

Italy

Contacts

Primary ContactPaolo Pelosi, Prof.
ppelosi@hotmail.com+39 335 5941740‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026