Ospedale Luigi Sacco
Milan, Lombardy, 20157, Italy
Completed
NCT Number: NCT01956422
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Continuous Positive Airway Pressure(CPAP)
DeviceVenturi Mask FiO2 40%
DevicePrimary outcomes
-
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
Time frame: 24 hours after the end of surgery
Secondary outcomes
-
Incidence of pneumonia
Time frame: Partecipants will be followed for the duration of hospital stay, an expected average of 1 week
Sponsors and collaborators
Lead sponsor
ASST Fatebenefratelli Sacco
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 8, 2013
- Registry last updated
- Jul 11, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.