General AnesthesiaNCT01267916
Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity
A study testing RR 6 + 0, RR 10 + 0 and RR 16 + 0 in people with General Anesthesia and Laparoscopic Cholecystectomy, run by Seoul Medical Center at 1 site in South Korea.
Trial summary
It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- General Anesthesia, Laparoscopic Cholecystectomy
- What is being tested?
- RR 6 + 0, RR 10 + 0 and RR 16 + 0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I or II obesity, Body-mass index > 27.5 undergoing laparoscopic cholecystectomy
Who cannot join
- patients with severe cardiopulmonary disease peak inspiratory pressure > 40 in the study setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.
It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.
Read the detailed description
Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.
The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.
- Conditions
- General Anesthesia, Laparoscopic Cholecystectomy
- Being tested
- RR 6 + 0, RR 10 + 0, RR 16 + 0, RR 6 + 5, RR 10 + 5
- Keywords
- intrinsic positive end-expiratory pressure, obesity, ventilator setting, respiratory rate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR 6 + 0Device
Also called Ventilator setting
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
RR 10 + 0Device
Also called Ventilator setting
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
RR 16 + 0Device
Also called Ventilator setting
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
RR 6 + 5Device
Also called Ventilator setting
Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
RR 10 + 5Device
Also called Ventilator setting
Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
RR 16 + 5Device
Also called Ventilator setting
Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
| Study group | Role | What they receive |
|---|---|---|
| RR 6 + 0 | Experimental | Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0 Receives: Device: RR 6 + 0 |
| RR 10 + 0 | Experimental | Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0 Receives: Device: RR 10 + 0 |
| RR 16 + 0 | Experimental | Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0 Receives: Device: RR 16 + 0 |
| RR 6 + 5 | Experimental | Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5 Receives: Device: RR 6 + 5 |
| RR 10 + 5 | Experimental | Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5 Receives: Device: RR 10 + 5 |
| RR 16 + 5 | Experimental | Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5 Receives: Device: RR 16 + 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas change parameters
PaO2 and PaCO2 the result of arterial blood gas analysis
Measured: 15 minute interval
Secondary outcomes (1)
intrinsic positive end-expiratory pressure
PEEPi measured by expiratory port occlusion method
Measured: every 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, Seoul Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267916
- Sponsor's protocol ID
- SMC-2010-12-13
- Status last verified
- Jan 2012
- First submitted
- 28 Dec 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity. Influence of Low Respiratory Rate With Unchanged Minute Volume.
- ClinicalTrials.gov ID
- NCT01267916
- Acronym / sponsor ID
- SMC-2010-12-13
- Conditions
- General Anesthesia, Laparoscopic Cholecystectomy
- Keywords
- intrinsic positive end-expiratory pressure, obesity, ventilator setting, respiratory rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Dec 2010 (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.
It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine position. The investigators tried to investigate the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.
Detailed description
Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It is known that there is a significant negative correlation between PEEPi present and PaO2. Therefore, the investigators postulated that if the reduce the PEEPi by reducing the respiratory rate in obese subjects, the impaired gas exchange might improve.
The investigators tried to research the effect of low respiratory rate and high tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RR 6 + 0 | Experimental | Device: RR 6 + 0Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0 |
| RR 10 + 0 | Experimental | Device: RR 10 + 0Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0 |
| RR 16 + 0 | Experimental | Device: RR 16 + 0Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0 |
| RR 6 + 5 | Experimental | Device: RR 6 + 5Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5 |
| RR 10 + 5 | Experimental | Device: RR 10 + 5Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5 |
| RR 16 + 5 | Experimental | Device: RR 16 + 5Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class I or II obesity, Body-mass index > 27.5 undergoing laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- patients with severe cardiopulmonary disease peak inspiratory pressure > 40 in the study setting
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 |
|---|---|---|
| RR 6 + 0Also: Ventilator settingRespiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0 | Device | RR 6 + 0 |
| RR 10 + 0Also: Ventilator settingRespiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0 | Device | RR 10 + 0 |
| RR 16 + 0Also: Ventilator settingRespiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0 | Device | RR 16 + 0 |
| RR 6 + 5Also: Ventilator settingRespiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5 | Device | RR 6 + 5 |
| RR 10 + 5Also: Ventilator settingRespiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5 | Device | RR 10 + 5 |
| RR 16 + 5Also: Ventilator settingRespiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5 | Device | RR 16 + 5 |
Primary outcome
Gas change parameters
Time frame: 15 minute interval
PaO2 and PaCO2 the result of arterial blood gas analysis
1 secondary outcome
intrinsic positive end-expiratory pressure
Time frame: every 15 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 31 Jan 2012.
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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?
A study testing RR 6 + 0, RR 10 + 0 and RR 16 + 0 in people with General Anesthesia and Laparoscopic Cholecystectomy, run by Seoul Medical Center at 1 site in South Korea.
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 31 Jan 2012. 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 South Korea. 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?
Gas change parameters (time frame: 15 minute interval). 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 31 Jan 2012.