Bariatric SurgeryNCT01890564
Modes of Ventilation During Laparoscopic Bariatric Surgery
An observational study of Bariatric Surgery, run by Joseph D. Tobias at 1 site in United States.
Trial summary
During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- PRVC ventilation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jan 2014
- Phase
- Observational
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Bariatric surgery patients
Who may be able to join
- Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).
- Conditions
- Bariatric Surgery
- Being tested
- Pressure controlled ventilation, Volume controlled ventilation, PRVC ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure controlled ventilationOther
For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.
Volume controlled ventilationOther
For volume controlled ventilation, the tidal volume is set.
PRVC ventilationOther
Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Patients undergoing bariatric surgery. Receives: Other: Pressure controlled ventilation; Other: Volume controlled ventilation; Other: PRVC ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.
Measured: Baseline to 30 mins.
Secondary outcomes (2)
Change in blood pressure
Blood pressure will be recorded every 5 mins. during each 30 minute mode of ventilation.
Measured: Baseline to 30 mins.
Blood gas
Blood gas will be obtained at the end of each 30 minute mode of ventilation.
Measured: 30 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890564
- Sponsor's protocol ID
- IRB12-00783
- Status last verified
- Mar 2014
- First submitted
- 27 Jun 2013
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modes of Ventilation During Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01890564
- Acronym / sponsor ID
- IRB12-00783
- Conditions
- Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Jul 2013 (estimated)
- 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.
During minimally invasive surgery, a pneumoperitoneum is created to facilitate surgical visualization. Although effective in facilitating the procedure, there are respiratory consequences of the pneumoperitoneum, which significantly increases intra-abdominal pressure (IAP) up to 20 cmH2O. The increased IAP can decrease functional residual capacity and increase closing capacity resulting in increased resistance, decreased compliance, and increased ventilation-perfusion mismatch. In a randomized, cross-over design, this study will evaluate in sequential order, 3 modes of ventilation during laparoscopic bariatric surgery to determine which is better able to support oxygenation and ventilation while limiting the peak inflating pressure (PIP).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | Other: Pressure controlled ventilation, Other: Volume controlled ventilation, Other: PRVC ventilationPatients undergoing bariatric surgery. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Bariatric surgery patients
Key inclusion criteria (1 listed)
- Laparoscopic bariatric surgery requiring intra-arterial blood pressure monitoring, age 14-20 years.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Pressure controlled ventilationFor pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath. | Other | Bariatric surgery |
| Volume controlled ventilationFor volume controlled ventilation, the tidal volume is set. | Other | Bariatric surgery |
| PRVC ventilationPressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target. | Other | Bariatric surgery |
Primary outcome
Change in heart rate
Time frame: Baseline to 30 mins.
Heart rate will be assessed every 5 mins. during each 30 minute mode of ventilation.
2 secondary outcomes
Change in blood pressure
Time frame: Baseline to 30 mins.
Blood gas
Time frame: 30 mins.
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 1 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Joseph D. Tobias at 1 site in United States.
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 1 inclusion and 1 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 1 Apr 2014. 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 United States. 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?
Change in heart rate (time frame: Baseline to 30 mins.). 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 1 Apr 2014.