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Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Laparoscopic Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03758937
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare volume controlled-ventilation (VCV) and pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric surgery.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Procedure: volume-controlled ventilation Procedure: pressure-controlled ventilation Not Applicable

Detailed Description:
Today, morbid obesity has become a global problem. It is not clear which mechanical ventilation mode will be used in bariatric surgery, which is one of the treatment options of these patients. VCV is the most commonly used mode to ventilate anesthetized patients. However, especially in obese patients, high airway pressures and hypoxia may occur due to increased intrapulmonary shunts. Therefore, we aimed to investigate the potential of PCV strategy to improve pulmonary gas exchange, respiratory mechanics and arterial blood gas values according to VCV in patients undergoing bariatric surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics in Laparoscopic Bariatric Surgery
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : August 1, 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: volume-controlled ventilation group
During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.
 Procedure: volume-controlled ventilation
Active Comparator: pressure-controlled ventilation group
During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.
 Procedure: pressure-controlled ventilation


Outcome Measures
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Primary Outcome Measures :
  1. Partial oxygen pressure [ Time Frame: 5 minutes after induction ]
    Assessed 5 minutes after induction by using arterial blood gas analysis.

  2. Partial oxygen pressure [ Time Frame: 30 minutes after pneumoperitoneum ]
    Assessed 30 minutes after pneumoperitoneum by using arterial blood gas

  3. Partial oxygen pressure [ Time Frame: through surgery completion, an average of 90 minutes ]
    Assessed through surgery completion, an average of 90 minutes by using arterial blood gas


Secondary Outcome Measures :
  1. Partial carbon dioxide pressure [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis.

  2. Partial carbon dioxide pressure - end-tidal carbon dioxide pressure [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis and end-tidal monitor.

  3. Peak airway pressure [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor.

  4. Dynamic compliance [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (Tidal volume/peak airway pressure - Positive end-expiratory pressure)

  5. Inspired oxygen pressure / Fractional oxygen ratio [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes

  6. Alveolar-arterial oxygen gradient pressure [ Time Frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes ]
    Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (D(A-a) O2).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or above,
  • ASA II patients
  • BMI > 40 kg / m2
  • No serious comorbidity.

Exclusion Criteria:

  • Unstable patients during the operation
  • The requirement for mechanical ventilation in the postoperative period.
Contacts and Locations
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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): NCT03758937


Locations
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Turkey
Antalya Traning and Research Hospital
Antalya, Turkey
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Study Director: Erhan Ozyurt, MD Antalya Training and Research Hospital
More Information
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03758937    
Other Study ID Numbers: AntalyaTRH31
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antalya Training and Research Hospital:
bariatric surgery
volume-controlled ventilation
pressure-controlled ventilation