Back to resultsEvaluation of Ventilatory Strategies During Laparoscopic Surgery
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
First arm: patients ventilated with zero end expiratory pressure
Patients ventilated with Positive End Expiratory Pressure
Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring atelectasis, laparoscopic surgery, anesthesia, mechanical ventilation, Prevent, shape of the airway, pressure-time curve
Eligibility Criteria
Inclusion Criteria:
- American Society Anesthesiology (ASA) I, II;
- age > 18 years;
- elective surgery
Exclusion Criteria:
- ASA III, IV;
- Age < 18 years;
- emergency surgery
Sites / Locations
- Maria Vittoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Patients ventilated with zero end expiratory pressure (ZEEP)
Patients ventilated with positive end expiratory pressure
recruitment plus PEEP
Arm Description
patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure
patients undergoing gynecologic laparoscopic surgery ventilated at PEEP
patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP
Outcomes
Primary Outcome Measures
Pulmonary Stress Index
Secondary Outcome Measures
Cardiac Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923038
Brief Title
Evaluation of Ventilatory Strategies During Laparoscopic Surgery
Official Title
Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Vittoria Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
atelectasis, laparoscopic surgery, anesthesia, mechanical ventilation, Prevent, shape of the airway, pressure-time curve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients ventilated with zero end expiratory pressure (ZEEP)
Arm Type
Active Comparator
Arm Description
patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure
Arm Title
Patients ventilated with positive end expiratory pressure
Arm Type
Active Comparator
Arm Description
patients undergoing gynecologic laparoscopic surgery ventilated at PEEP
Arm Title
recruitment plus PEEP
Arm Type
Active Comparator
Arm Description
patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP
Intervention Type
Procedure
Intervention Name(s)
First arm: patients ventilated with zero end expiratory pressure
Intervention Type
Procedure
Intervention Name(s)
Patients ventilated with Positive End Expiratory Pressure
Intervention Type
Procedure
Intervention Name(s)
Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
Primary Outcome Measure Information:
Title
Pulmonary Stress Index
Time Frame
Continuous evaluation during time of surgery. Partecipants will be followed for the duration of hospital stay, an expected average of 1 weeks
Secondary Outcome Measure Information:
Title
Cardiac Index
Time Frame
Continuous evaluation during the time of surgery
Other Pre-specified Outcome Measures:
Title
Blood gases
Time Frame
Continuous evaluation during the time of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society Anesthesiology (ASA) I, II;
age > 18 years;
elective surgery
Exclusion Criteria:
ASA III, IV;
Age < 18 years;
emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilpaolo Manno, MD
Organizational Affiliation
Maria Vittoria Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Maria Vittoria Hospital
City
Turin
ZIP/Postal Code
10149
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Ventilatory Strategies During Laparoscopic Surgery
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