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

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ClinicalTrials.gov Identifier: NCT01956422

Recruitment Status : Completed

First Posted : October 8, 2013

Last Update Posted : July 11, 2014

Sponsor:

Information provided by (Responsible Party):

Tommaso Fossali, ASST Fatebenefratelli Sacco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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]	Device: Continuous Positive Airway Pressure(CPAP) Device: Venturi Mask FiO2 40%	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	48 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	August 2013
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continuous Positive Airway Pressure(CPAP) In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours.	Device: Continuous Positive Airway Pressure(CPAP)
Active Comparator: Venturi Mask FiO2 40% In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask	Device: Venturi Mask FiO2 40%

Outcome Measures

Primary Outcome Measures :

Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline) [ Time Frame: 24 hours after the end of surgery ]

Secondary Outcome Measures :

Incidence of pneumonia [ Time Frame: Partecipants will be followed for the duration of hospital stay, an expected average of 1 week ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956422

Locations

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Italy
Ospedale Luigi Sacco
Milano, Lombardia, Italy, 20157

Sponsors and Collaborators

ASST Fatebenefratelli Sacco

Investigators

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Principal Investigator:	Tommaso Fossali, Consultant	ASST Fatebenefratelli Sacco

More Information

Publications:

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. Review.

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.

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Responsible Party:	Tommaso Fossali, Consultant, ASST Fatebenefratelli Sacco
ClinicalTrials.gov Identifier:	NCT01956422
Other Study ID Numbers:	CE#382/2013
First Posted:	October 8, 2013 Key Record Dates
Last Update Posted:	July 11, 2014
Last Verified:	July 2014

Additional relevant MeSH terms:

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Pneumoperitoneum Peritoneal Diseases Digestive System Diseases

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