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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03758937
Other study ID # AntalyaTRH31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date August 1, 2017

Study information

Verified date November 2018
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 1, 2017
Est. primary completion date April 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
volume-controlled ventilation

pressure-controlled ventilation


Locations

Country Name City State
Turkey Antalya Traning and Research Hospital Antalya

Sponsors (1)

Lead Sponsor Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Partial oxygen pressure Assessed 5 minutes after induction by using arterial blood gas analysis. 5 minutes after induction
Primary Partial oxygen pressure Assessed 30 minutes after pneumoperitoneum by using arterial blood gas 30 minutes after pneumoperitoneum
Primary Partial oxygen pressure Assessed through surgery completion, an average of 90 minutes by using arterial blood gas through surgery completion, an average of 90 minutes
Secondary Partial carbon dioxide pressure Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis. 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Secondary Partial carbon dioxide pressure - end-tidal carbon dioxide pressure 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. 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Secondary Peak airway pressure Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor. 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Secondary Dynamic compliance 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 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Secondary Inspired oxygen pressure / Fractional oxygen ratio Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Secondary Alveolar-arterial oxygen gradient pressure 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). 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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