Clinical trial NCT01956422: Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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]
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
measure: Incidence of pneumonia
timeFrame: Partecipants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
state: Lombardia
Study officials:
affiliation: ASST Fatebenefratelli Sacco
name: Tommaso Fossali, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreyra GP, Baussano I, Squadrone V, Richiardi L, Marchiaro G, Del Sorbo L, Mascia L, Merletti F, Ranieri VM. Continuous positive airway pressure for treatment of respiratory complications after abdominal surgery: a systematic review and meta-analysis. Ann Surg. 2008 Apr;247(4):617-26. doi: 10.1097/SLA.0b013e3181675829.
citation: Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.