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

Continuous Positive Airway Pressure [E02.041.625.790.259] Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956422
• Other study ID #: CE#382/2013
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: July 10, 2014
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Ospedale L. Sacco – Polo Universitario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Continuous Positive Airway Pressure(CPAP)

• Venturi Mask FiO2 40%

Locations

Country	Name	City	State
Italy	Ospedale Luigi Sacco	Milano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale L. Sacco – Polo Universitario

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)		24 hours after the end of surgery	Yes
Secondary	Incidence of pneumonia		Partecipants will be followed for the duration of hospital stay, an expected average of 1 week	Yes