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Completed

NCT Number: NCT03758937

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

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.

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Key information

Conditions

Bariatric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Traning and Research Hospital

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Volume-Controlled Ventilation

Procedure

pressure-controlled ventilation

Procedure

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics in Laparoscopic Bariatric Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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