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Evaluation of Ventilatory Strategies During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01923038
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Emilpaolo Manno, Maria Vittoria Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumonia 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-expansion of Atelectasis During Laparoscopic Surgery. Recruitment Maneuver vs Positive End-expiratory Pressure: a Randomized Study
Study Start Date : November 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Active Comparator: Patients ventilated with zero end expiratory pressure (ZEEP)
patients undergoing gynecologic laparoscopic surgery ventilated at zero end expiratory pressure
Procedure: First arm: patients ventilated with zero end expiratory pressure
Active Comparator: Patients ventilated with positive end expiratory pressure
patients undergoing gynecologic laparoscopic surgery ventilated at PEEP
Procedure: Patients ventilated with Positive End Expiratory Pressure
Active Comparator: recruitment plus PEEP
patients undergoing gynecologic laparoscopic surgery undergoing recruitment plus PEEP
Procedure: Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver



Primary Outcome Measures :
  1. 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 Measures :
  1. Cardiac Index [ Time Frame: Continuous evaluation during the time of surgery ]

Other Outcome Measures:
  1. Blood gases [ Time Frame: Continuous evaluation during the time of surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society Anesthesiology (ASA) I, II;
  • age > 18 years;
  • elective surgery

Exclusion Criteria:

  • ASA III, IV;
  • Age < 18 years;
  • emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923038


Locations
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Italy
Maria Vittoria Hospital
Turin, Italy, 10149
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
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Study Director: Emilpaolo Manno, MD Maria Vittoria Hospital

Additional Information:

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Responsible Party: Emilpaolo Manno, Emergency Department Director, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01923038     History of Changes
Other Study ID Numbers: BCB232
MariaVittoria Hospital ( Other Identifier: MariaVittoria Hospital )
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Emilpaolo Manno, Maria Vittoria Hospital:
atelectasis
laparoscopic surgery
anesthesia
mechanical ventilation
Prevent
shape of the airway
pressure-time curve

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections