Sleep Apnea, ObstructiveLMANCT01695980
Laryngeal Mask Airway in Pediatric Adenotonsillectomy
A study testing ETT with non modified retractor and LMA with modified retractor in people with Sleep Apnea, Obstructive and Tonsillitis, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Tonsillitis
- What is being tested?
- ETT with non modified retractor and LMA with modified retractor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 29 Mar 2022
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16
Who cannot join
- children with BMI >35
- unwillingness to comply with study procedures
- children with craniofacial anomalies/abnormalities which will interfere with mask placement
- children under 2 or over 16
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.
Read the detailed description
The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost.
The child will be randomized into either the LMA group or the ETT group.
- Conditions
- Sleep Apnea, Obstructive, Tonsillitis
- Being tested
- ETT with non modified retractor, LMA with modified retractor
- Keywords
- adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT with non modified retractorProcedure or surgery
adenotonsillectomy
LMA with modified retractorOther
LMA with modified retractor
| Study group | Role | What they receive |
|---|---|---|
| LMA with modified retractor | Experimental | LMA with modified retractor Receives: Other: LMA with modified retractor |
| ETT with non modified retractor | Active comparator | ETT with non modified retractor Receives: Procedure: ETT with non modified retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.
Measured: one year
Secondary outcomes (1)
To determine total length of procedure and recovery time with use the LMA.
Does the rate of kinking/obstruction of the tubing cause prolonged procedure time and additional issues for anesthesia and the subsequent recovery of the patient.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startAug 2012
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Baldassari M.D., Eastern Virginia Medical School
- Investigators
- Christina Baldassari, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695980
- Sponsor's protocol ID
- version 4 25Jun2012
- Acronym
- LMA
- Status last verified
- Apr 2022
- First submitted
- 24 Sep 2012
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway in Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT01695980
- Acronym / sponsor ID
- LMA / version 4 25Jun2012
- Conditions
- Sleep Apnea, Obstructive, Tonsillitis
- Keywords
- adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 28 Sep 2012 (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 study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.
Detailed description
The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost.
The child will be randomized into either the LMA group or the ETT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA with modified retractor | Experimental | Other: LMA with modified retractorLMA with modified retractor |
| ETT with non modified retractor | Active comparator | Procedure: ETT with non modified retractorETT with non modified retractor |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16
Key exclusion criteria (4 listed)
- children with BMI >35
- unwillingness to comply with study procedures
- children with craniofacial anomalies/abnormalities which will interfere with mask placement
- children under 2 or over 16
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 |
|---|---|---|
| ETT with non modified retractoradenotonsillectomy | Procedure or surgery | ETT with non modified retractor |
| LMA with modified retractorLMA with modified retractor | Other | LMA with modified retractor |
Primary outcome
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.
Time frame: one year
Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.
1 secondary outcome
To determine total length of procedure and recovery time with use the LMA.
Time frame: One year
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 11 Apr 2022.
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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.
Christina Baldassari, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT with non modified retractor and LMA with modified retractor in people with Sleep Apnea, Obstructive and Tonsillitis, run by Eastern Virginia Medical School 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 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 11 Apr 2022. 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?
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy. (time frame: one year). 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 11 Apr 2022.