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

ASST Fatebenefratelli Sacco

Status: Completed

Conditions: Pneumoperitoneum [C06.844.670]; Laparoscopy [E01.370.388.250.520]; Continuous Positive Airway Pressure [E02.041.625.790.259]; Prostatectomy [E04.950.774.860.625]

Treatments: Device: Venturi Mask FiO2 40%; Device: Continuous Positive Airway Pressure(CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01956422

CE#382/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Continuous Positive Airway Pressure(CPAP)

Experimental group

Description:

In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours.

Treatment:

Device: Continuous Positive Airway Pressure(CPAP)

Venturi Mask FiO2 40%

Active Comparator group

Description:

In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask

Treatment:

Device: Venturi Mask FiO2 40%