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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01956422

Enrollment

Registered

2013-10-08

Start date

2013-08-31

Completion date

2014-07-31

Last updated

2014-07-11

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

Conditions

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

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.

Interventions

DEVICEContinuous Positive Airway Pressure(CPAP)

DEVICEVenturi Mask FiO2 40%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

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