Evaluation of Ventilatory Strategies During Laparoscopic Surgery

Study Overview
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Brief Summary
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Atelectasis involving declive areas often occurs during general anesthesia and may persist postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress Index (SI), during constant flow inflation can lead ventilator setting during general anesthesia.

Official Title
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Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study

Conditions
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Pneumonia

Intervention / Treatment
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* Procedure: First arm: patients ventilated with zero end expiratory pressure
* Procedure: Patients ventilated with Positive End Expiratory Pressure
* Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society Anesthesiology (ASA) I, II; age > 18 years; elective surgery Exclusion Criteria: ASA III, IV; Age < 18 years; emergency surgery

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Patients ventilated with zero end expiratory pressure (ZEEP)<br>patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure | Procedure: First arm: patients ventilated with zero end expiratory pressure<br> <br> |
| Active Comparator: Patients ventilated with positive end expiratory pressure<br>patients undergoing gynecologic laparoscopic surgery ventilated at PEEP | Procedure: Patients ventilated with Positive End Expiratory Pressure<br> <br> |
| Active Comparator: recruitment plus PEEP<br>patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP | Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Stress Index |  | Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index |  | Continuous evaluation during the time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atelectasis, laparoscopic surgery, anesthesia, mechanical ventilation, Prevent, shape of the airway, pressure-time curve