Laryngeal Mask AirwayNCT01141660
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
A study testing Endotracheal Tube and Laryngeal mask airway in people with Laryngeal Mask Airway and Tonsillectomy, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Laryngeal Mask Airway, Tonsillectomy
- What is being tested?
- Endotracheal Tube and Laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.
Who cannot join
- Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virigina Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.
- Conditions
- Laryngeal Mask Airway, Tonsillectomy
- Being tested
- Endotracheal Tube, Laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal TubeDevice
Also called ETT, Endotracheal intubation
Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
Laryngeal mask airwayDevice
Also called LMA
Randomized to either Laryngeal mask airway or endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Tube | Experimental | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. Receives: Device: Endotracheal Tube |
| Laryngeal Mask Airway | Experimental | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. Receives: Device: Laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Laryngospasm
Measured: 2 years
Secondary outcomes (1)
Postanesthesia Recovery Times
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelley Dodson, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141660
- Sponsor's protocol ID
- HM10692
- Status last verified
- Oct 2017
- First submitted
- 7 Jun 2010
- Last updated
- 13 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3. doi: 10.1093/bja/70.1.30.
PubMed 8240471
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT01141660
- Acronym / sponsor ID
- HM10692
- Conditions
- Laryngeal Mask Airway, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 13 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Tube | Experimental | Device: Endotracheal TubeChildren undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
| Laryngeal Mask Airway | Experimental | Device: Laryngeal mask airwayChildren undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.
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 TubeAlso: ETT, Endotracheal intubationPatients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy. | Device | Endotracheal Tube |
| Laryngeal mask airwayAlso: LMARandomized to either Laryngeal mask airway or endotracheal tube | Device | Laryngeal Mask Airway |
Primary outcome
Number of Participants With Laryngospasm
Time frame: 2 years
1 secondary outcome
Postanesthesia Recovery Times
Time frame: After surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8240471Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3. doi: 10.1093/bja/70.1.30.
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Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
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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.
Kelley Dodson, MD principal investigator
Virginia Commonwealth University
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 Tube and Laryngeal mask airway in people with Laryngeal Mask Airway and Tonsillectomy, run by Virginia Commonwealth University 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 13 Nov 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?
Yes. Results are posted in the registry (first posted 13 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Laryngospasm (time frame: 2 years). 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 NCT01141660, 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 13 Nov 2017.