General SurgeryNCT03056807
Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia
A study testing 25° head-up position and 55° head-up position in people with General Surgery, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- General Surgery
- What is being tested?
- 25° head-up position and 55° head-up position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II-III patients
- Body Mass Index (BMI) of 40-60
- Scheduled for an elective laparoscopic adjustable gastric band surgery
Who cannot join
- Patients with abnormalities of the upper airway that require awake tracheal intubation
- Asthma
- Chronic obstructive pulmonary disease
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.
- Conditions
- General Surgery
- Being tested
- 25° head-up position, 55° head-up position
- Keywords
- tolerable apneic time, bariatric surgery, gastric band surgery, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25° head-up positionOther
Angle person is positioned for procedure.
55° head-up positionOther
Angle person is positioned for procedure.
| Study group | Role | What they receive |
|---|---|---|
| A - 25° head-up position | Active comparator | Participants will be positioned at a 25° head-up position for procedure. Receives: Other: 25° head-up position |
| B - 55° head-up position | Active comparator | Participants will be positioned at a 55° head-up position for procedure. Receives: Other: 55° head-up position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerable Apneic Time (TAT)
Measure of the TAT between groups to determine if the TAT is a function of the participant's position.
Measured: Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes
Secondary outcomes (2)
Length of time to intubation (TTI)
Measured: Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes
Peripheral arterial hemoglobin oxygen saturation (SpO2) trough
Measure of the rebound SpO2. It is the lowest SpO2 reading reached subsequent to start of mechanical ventilation at the SpO2 value of 94% and it represents final completion of SpO2 decline.
Measured: Time until SpO2 decreased to 92%, up to 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startOct 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirsad Dupanović, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056807
- Sponsor's protocol ID
- 11506
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT03056807
- Acronym / sponsor ID
- 11506
- Conditions
- General Surgery
- Keywords
- tolerable apneic time, bariatric surgery, gastric band surgery, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Feb 2017 (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 the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - 25° head-up position | Active comparator | Other: 25° head-up positionParticipants will be positioned at a 25° head-up position for procedure. |
| B - 55° head-up position | Active comparator | Other: 55° head-up positionParticipants will be positioned at a 55° head-up position for procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status II-III patients
- Body Mass Index (BMI) of 40-60
- Scheduled for an elective laparoscopic adjustable gastric band surgery
Key exclusion criteria (4 listed)
- Patients with abnormalities of the upper airway that require awake tracheal intubation
- Asthma
- Chronic obstructive pulmonary disease
- Pregnant patients
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 |
|---|---|---|
| 25° head-up positionAngle person is positioned for procedure. | Other | A - 25° head-up position |
| 55° head-up positionAngle person is positioned for procedure. | Other | B - 55° head-up position |
Primary outcome
Tolerable Apneic Time (TAT)
Time frame: Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes
Measure of the TAT between groups to determine if the TAT is a function of the participant's position.
2 secondary outcomes
Length of time to intubation (TTI)
Time frame: Time between start of the tracheal intubation procedure to completion of tracheal intubation, up to 2 minutes
Peripheral arterial hemoglobin oxygen saturation (SpO2) trough
Time frame: Time until SpO2 decreased to 92%, up to 8 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 17 Feb 2017.
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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.
Mirsad Dupanović, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25° head-up position and 55° head-up position in people with General Surgery, run by University of Kansas Medical Center 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 3 inclusion and 4 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 17 Feb 2017. 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?
Tolerable Apneic Time (TAT) (time frame: Time between start of induction of general anesthesia (SpO2 100%) to decline of SpO2 94%, up to eight minutes). 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 17 Feb 2017.