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

Primary Purpose

Continuous Positive Airway Pressure [E02.041.625.790.259], Prostatectomy [E04.950.774.860.625], Laparoscopy [E01.370.388.250.520]

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure(CPAP)
Venturi Mask FiO2 40%
Sponsored by
ASST Fatebenefratelli Sacco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Continuous Positive Airway Pressure [E02.041.625.790.259]

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Luigi Sacco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Positive Airway Pressure(CPAP)

Venturi Mask FiO2 40%

Arm Description

In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours.

In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask

Outcomes

Primary Outcome Measures

Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)

Secondary Outcome Measures

Incidence of pneumonia

Full Information

First Posted
September 27, 2013
Last Updated
July 10, 2014
Sponsor
ASST Fatebenefratelli Sacco
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1. Study Identification

Unique Protocol Identification Number
NCT01956422
Brief Title
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Fatebenefratelli Sacco

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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]

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure(CPAP)
Arm Type
Experimental
Arm Description
In the first 24 hours after laparoscopic prostatectomy patients undergo 3 CPAP cycles (PEEP 7.5, FIO2 40% delivered with Helmet)lasting 2 hours.
Arm Title
Venturi Mask FiO2 40%
Arm Type
Active Comparator
Arm Description
In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure(CPAP)
Intervention Type
Device
Intervention Name(s)
Venturi Mask FiO2 40%
Primary Outcome Measure Information:
Title
Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline)
Time Frame
24 hours after the end of surgery
Secondary Outcome Measure Information:
Title
Incidence of pneumonia
Time Frame
Partecipants will be followed for the duration of hospital stay, an expected average of 1 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommaso Fossali, Consultant
Organizational Affiliation
ASST Fatebenefratelli Sacco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Luigi Sacco
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18362624
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.
Results Reference
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PubMed Identifier
15687314
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.
Results Reference
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Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy

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