Trials / Completed
CompletedNCT01956422
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- ASST Fatebenefratelli Sacco · Academic / Other
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Continuous Positive Airway Pressure [E02.041.625.790.259]
- Prostatectomy [E04.950.774.860.625]
- Laparoscopy [E01.370.388.250.520]
- Pneumoperitoneum [C06.844.670]
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Positive Airway Pressure(CPAP) | |
| DEVICE | Venturi Mask FiO2 40% |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2013-10-08
- Last updated
- 2014-07-11
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01956422. Inclusion in this directory is not an endorsement.