Evaluation of Ventilatory Strategies During Laparoscopic Surgery

NCT ID: NCT01923038

Last Updated: 2014-01-20

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-08-31

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.

Detailed Description

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Conditions

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Pneumonia

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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Patients ventilated with zero end expiratory pressure (ZEEP)

patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure

Group Type ACTIVE_COMPARATOR

First arm: patients ventilated with zero end expiratory pressure

Intervention Type PROCEDURE

Patients ventilated with positive end expiratory pressure

patients undergoing gynecologic laparoscopic surgery ventilated at PEEP

Group Type ACTIVE_COMPARATOR

Patients ventilated with Positive End Expiratory Pressure

Intervention Type PROCEDURE

recruitment plus PEEP

patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP

Group Type ACTIVE_COMPARATOR

Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

Intervention Type PROCEDURE

Interventions

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First arm: patients ventilated with zero end expiratory pressure

Intervention Type PROCEDURE

Patients ventilated with Positive End Expiratory Pressure

Intervention Type PROCEDURE

Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maria Vittoria Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emilpaolo Manno

Emergency Department Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilpaolo Manno, MD

Role: STUDY_DIRECTOR

Maria Vittoria Hospital

Locations

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Maria Vittoria Hospital

Turin, Turin, Italy

Site Status

Countries

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Italy

Other Identifiers

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MariaVittoria Hospital

Identifier Type: OTHER

Identifier Source: secondary_id

BCB232

Identifier Type: -

Identifier Source: org_study_id

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