ObesityPhase 4NCT01124825
Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
A Phase 4 study testing IGEL and King airway in people with Obesity, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- IGEL and King airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2012
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective surgery with an estimated duration of 30 to 120 minutes
- American Society of Anesthesiologists (ASA) status I-III
- Aged 18 to 65 years.
- Body mass index (BMI) ≥ 35 kg/m2
Who cannot join
- A history of difficult intubation;
- Immobilized cervical spine;
- Oxygen saturation less than 95% at room air;
- A history of uncontrolled gastroesophageal reflux or hiatus hernia;
- A history of ulcer surgery including vagotomy;
- Previous gastric bypass surgery;
Show all 10Show fewer
- Diabetic gastroparesis;
- Patients with known coagulation disorders (e.g. hemophilias, von Willebrand disease, factor V leiden diseases) or on systemic anticoagulation drugs (e.g. continuous heparin infusion); Patients with abnormal coagulation tests will be also excluded. However, asymptomatic patients will not be tested on any coagulation disorders.
- Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
- Pregnant or breast-feeding (pregnancy status will be confirmed by a pregnancy test, as it is standard for all surgical procedures at the University hospital).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.
- Conditions
- Obesity
- Being tested
- IGEL, King airway
- Keywords
- Anesthesia induction and maintenance, Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGELDevice
iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation
King airwayDevice
KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| IGel | Active comparator | Subjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation Receives: Device: IGEL |
| King Airway | Active comparator | Subject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation Receives: Device: King airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Sealing Pressure
Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.
Measured: 1-3 hours
Secondary outcomes (1)
Difference in insertion time for one of the supraglottic airway devices
Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJul 2011
- Primary completionMay 2012 (estimated)
- Study completionOct 2012
Why it stopped: No subjects enrolled. Funding withdrawn by sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Detlef Obal, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124825
- Sponsor's protocol ID
- UofL IRB #09.0619
- Status last verified
- Nov 2012
- First submitted
- 12 May 2010
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
PubMed 19293691
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01124825
- Acronym / sponsor ID
- UofL IRB #09.0619
- Conditions
- Obesity
- Keywords
- Anesthesia induction and maintenance, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled. Funding withdrawn by sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 May 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.
The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGel | Active comparator | Device: IGELSubjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation |
| King Airway | Active comparator | Device: King airwaySubject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for elective surgery with an estimated duration of 30 to 120 minutes
- American Society of Anesthesiologists (ASA) status I-III
- Aged 18 to 65 years.
- Body mass index (BMI) ≥ 35 kg/m2
Key exclusion criteria (10 listed)
- A history of difficult intubation;
- Immobilized cervical spine;
- Oxygen saturation less than 95% at room air;
- A history of uncontrolled gastroesophageal reflux or hiatus hernia;
- A history of ulcer surgery including vagotomy;
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 |
|---|---|---|
| IGELiGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation | Device | IGel |
| King airwayKING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation | Device | King Airway |
Primary outcome
Airway Sealing Pressure
Time frame: 1-3 hours
Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.
1 secondary outcome
Difference in insertion time for one of the supraglottic airway devices
Time frame: 1-3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Background: PubMed 19293691Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Detlef Obal, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IGEL and King airway in people with Obesity, run by University of Louisville 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 14 Nov 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Airway Sealing Pressure (time frame: 1-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124825, which also lists 1 linked publication.
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 14 Nov 2012.