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

NCT ID: NCT01956422

Last Updated: 2014-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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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]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure(CPAP)

Intervention Type DEVICE

Venturi Mask FiO2 40%

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

Group Type ACTIVE_COMPARATOR

Venturi Mask FiO2 40%

Intervention Type DEVICE

Interventions

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Continuous Positive Airway Pressure(CPAP)

Intervention Type DEVICE

Venturi Mask FiO2 40%

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ASST Fatebenefratelli Sacco

OTHER

Sponsor Role lead

Responsible Party

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Tommaso Fossali

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tommaso Fossali, Consultant

Role: PRINCIPAL_INVESTIGATOR

ASST Fatebenefratelli Sacco

Locations

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Ospedale Luigi Sacco

Milan, Lombardy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18362624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15687314 (View on PubMed)

Other Identifiers

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CE#382/2013

Identifier Type: -

Identifier Source: org_study_id

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