Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy

Not Applicable

Completed

• Conditions: Pneumoperitoneum [C06.844.670]; Prostatectomy [E04.950.774.860.625]; Continuous Positive Airway Pressure [E02.041.625.790.259]; Laparoscopy [E01.370.388.250.520]
• Interventions: Device: Venturi Mask FiO2 40%; Device: Continuous Positive Airway Pressure(CPAP)

• Registration Number: NCT01956422
• Lead Sponsor: ASST Fatebenefratelli Sacco

Brief Summary

Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2\<60 mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal value.

Detailed Description

Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However, the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP) improves oxygenation and reduces the rate of re-intubation in the presence of PORF.

The aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of CPAP, compared with Venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry.

CPAP is delivered with "CASTAR" Helmet by StarMed.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-10-06
• Study First Posted: 2013-10-08
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Patients scheduled for elective laparoscopic prostatectomy
• American Society of Anesthesiologists status I-II

Exclusion Criteria

• Cardiac functional status New York Heart Association (NYHA) >II
• Chronic Obstructive Pulmonary Disease (COPD) Gold Class >2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venturi Mask FiO2 40%	Venturi Mask FiO2 40%	In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask
Continuous Positive Airway Pressure(CPAP)	Continuous Positive Airway Pressure(CPAP)	In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)	24 hours after the end of surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of pneumonia	Partecipants will be followed for the duration of hospital stay, an expected average of 1 week

Trial Locations

Locations (1)

Ospedale Luigi Sacco; 🇮🇹 Milano, Lombardia, Italy