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

Study Overview
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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]

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure(CPAP)
* Device: Venturi Mask FiO2 40%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure(CPAP)<br>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)<br> <br> |
| Active Comparator: Venturi Mask FiO2 40%<br>In the first 24 hours after laparoscopic prostatectomy patients breathe Oxygen 40% delivered with Venturi Mask | Device: Venturi Mask FiO2 40%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative respiratory failure (PaO2<60mmHg, FEV1<70% of baseline) |  | 24 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumonia |  | Partecipants will be followed for the duration of hospital stay, an expected average of 1 week |