Perioperative Respiratory Adverse EventsNCT03996343
Airway Management and Weight in Children
A study testing Endotracheal intubation and Laryngeal mask airway in people with Perioperative Respiratory Adverse Events and Airway Management, run by University of Michigan at 1 site in United States.
Trial summary
The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in… Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Respiratory Adverse Events, Airway Management
- What is being tested?
- Endotracheal intubation and Laryngeal mask 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
- May 2019to Jun 2021
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- sex-specific body mass index (BMI) is ≥85th percentile
- elective surgical outpatient peripheral or lower abdominal procedures
- Surgery length estimated to last between 30 and 120 minutes
Who cannot join
- Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
- Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
- Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
- Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
- Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children
The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).
- Being tested
- Endotracheal intubation, Laryngeal mask airway
- Keywords
- Laryngeal mask airway, Endotracheal intubation, Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
COMPLETE
Laryngeal mask airwayDevice
COMPLETE
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal intubation | Experimental | Not described Receives: Device: Endotracheal intubation |
| Laryngeal mask airway | Experimental | Not described Receives: Device: Laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe respiratory adverse events
laryngospasm, bronchospasm
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study startMay 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Investigator leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Respiratory Adverse EventsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olubukola Nafiu, University of Michigan
- Investigators
- Olubukola Nafiu, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996343
- Sponsor's protocol ID
- HUM00132290
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children
- ClinicalTrials.gov ID
- NCT03996343
- Acronym / sponsor ID
- HUM00132290
- Keywords
- Laryngeal mask airway, Endotracheal intubation, Obese
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Jun 2019 (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 investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation | Experimental | Device: Endotracheal intubation |
| Laryngeal mask airway | Experimental | Device: Laryngeal mask airway |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- sex-specific body mass index (BMI) is ≥85th percentile
- elective surgical outpatient peripheral or lower abdominal procedures
- Surgery length estimated to last between 30 and 120 minutes
Key exclusion criteria (5 listed)
- Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
- Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
- Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
- Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
- Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.
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 |
|---|---|---|
| Endotracheal intubationCOMPLETE | Device | Endotracheal intubation |
| Laryngeal mask airwayCOMPLETE | Device | Laryngeal mask airway |
Primary outcome
Severe respiratory adverse events
Time frame: perioperative period
laryngospasm, bronchospasm
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 24 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Olubukola Nafiu, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation and Laryngeal mask airway in people with Perioperative Respiratory Adverse Events and Airway Management, run by University of Michigan 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 5 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 24 Jun 2019. 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 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?
Severe respiratory adverse events (time frame: perioperative period). 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 24 Jun 2019.