Bariatric SurgeryNCT03758937
Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Laparoscopic Bariatric Surgery
A study of Bariatric Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or above,
- ASA II patients
- BMI > 40 kg / m2
- No serious comorbidity.
Who cannot join
- Unstable patients during the operation
- The requirement for mechanical ventilation in the postoperative period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics 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.
Read the 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.
- Conditions
- Bariatric Surgery
- Being tested
- volume-controlled ventilation, pressure-controlled ventilation
- Keywords
- bariatric surgery, volume-controlled ventilation, pressure-controlled ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume-controlled ventilationProcedure or surgery
pressure-controlled ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| volume-controlled ventilation group | Active comparator | 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. Receives: Procedure: volume-controlled ventilation |
| pressure-controlled ventilation group | Active comparator | 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. Receives: Procedure: pressure-controlled ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial oxygen pressure
Assessed 5 minutes after induction by using arterial blood gas analysis.
Measured: 5 minutes after induction
Partial oxygen pressure
Assessed 30 minutes after pneumoperitoneum by using arterial blood gas
Measured: 30 minutes after pneumoperitoneum
Partial oxygen pressure
Assessed through surgery completion, an average of 90 minutes by using arterial blood gas
Measured: through surgery completion, an average of 90 minutes
Secondary outcomes (6)
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.
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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.
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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.
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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)
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Inspired oxygen pressure / Fractional oxygen ratio
Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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).
Measured: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erhan Ozyurt, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758937
- Sponsor's protocol ID
- AntalyaTRH31
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics in Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03758937
- Acronym / sponsor ID
- AntalyaTRH31
- Conditions
- Bariatric Surgery
- Keywords
- bariatric surgery, volume-controlled ventilation, pressure-controlled ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| volume-controlled ventilation group | Active comparator | Procedure: volume-controlled ventilationDuring 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. |
| pressure-controlled ventilation group | Active comparator | Procedure: pressure-controlled ventilationDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or above,
- ASA II patients
- BMI > 40 kg / m2
- No serious comorbidity.
Key exclusion criteria (2 listed)
- Unstable patients during the operation
- The requirement for mechanical ventilation in the postoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| volume-controlled ventilation | Procedure or surgery | volume-controlled ventilation group |
| pressure-controlled ventilation | Procedure or surgery | pressure-controlled ventilation group |
Primary outcome
Partial oxygen pressure
Time frame: 5 minutes after induction
Assessed 5 minutes after induction by using arterial blood gas analysis.
Partial oxygen pressure
Time frame: 30 minutes after pneumoperitoneum
Assessed 30 minutes after pneumoperitoneum by using arterial blood gas
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
6 secondary outcomes
Partial carbon dioxide pressure
Time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
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
Peak airway pressure
Time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Dynamic compliance
Time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Inspired oxygen pressure / Fractional oxygen ratio
Time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Alveolar-arterial oxygen gradient pressure
Time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Ozyurt, MD study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bariatric Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial oxygen pressure (time frame: 5 minutes after induction). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.