Airway MorbidityNCT01936662
Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy
A study testing LMA and ETT in people with Airway Morbidity, run by Indiana University at 1 site in United States.
Trial summary
Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or without associated biopsies, is relatively short in length. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- LMA and ETT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2013
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled for Esophagogastroduodenoscopy, with or without biopsies
- Have been informed of the nature of the study and informed consent has been obtained from the legally responsible
- Have provided assent in accordance with Institutional Review Board requirements
- Are able to complete pain assessment evaluations as determined by preoperative evaluations
Who cannot join
- • Abnormal/difficult airway
- Symptomatic obstructive sleep apnea
- Risk of aspiration of stomach contents
- Upper respiratory infection within last 14 days
- Allergy to lidocaine or ondansetron
- EGD procedures associated with the need to exclude ondansetron administration
Show all 9Show fewer
- BMI >85th percentile for age
- Are unable to communicate effectively with study personnel
- Have a positive urine pregnancy test (menstruating females only at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
About this study
Official title: Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or without associated biopsies, is relatively short in length. Unlike adults, who regularly undergo this procedure with conscious sedation, children most often require general anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children for EGD can result in delayed awakening and slow room turnover, particularly when intravenous medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to intubation, which permits removal before full awakening.
Although considered a safe alternative to tracheal intubation in appropriate cases, disadvantages of the LMA have been reported including kinking, occluding view of the surgical field, failure of placement requiring tracheal intubation, aspiration of gastric contents, desaturation, and laryngospasm. The study was designed to determine whether use of an LMA for EGD could reduce operating room time, while providing satisfactory conditions for the endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise healthy children with gastrointestinal complaints
Read the detailed description
- Study design The study will be randomized, controlled, and prospective in design.
- Comparison groups The two comparison groups will be:
- Laryngeal Mask Airway Group (LMA), N = 42 LMA will be used as the intraoperative airway device.
- Endotracheal Tube Group (ETT), N = 42 ETT will be used as the intraoperative airway device.
- Study and timeline of interventions
- Preoperative: All patients enrolled in this study will receive a standard preoperative dose of oral midazolam 0.5 mg/kg up to 15 mg, 15 to 30 minutes prior to anesthetic induction.
- Intraoperative: Subjects will all undergo induction of anesthesia by inhalation of sevoflurane and oxygen. An intravenous catheter (IV) will be placed, followed by lidocaine 2mg/kg IV. The airway device will be placed (LMA or ETT). As required for the procedure, the subject will be placed in a left lateral decubitus (left side down) position. Maintenance of anesthesia will be provided with sevoflurane at a concentration of 1.5-2 MAC, or higher if deemed appropriate for the clinical setting as judged by the anesthesiologist. All participants will be given the anti-nausea medicine ondansetron 0.1mg/kg (maximum 4 mg) after placement of the airway device. When the endoscope is removed at the completion of the procedure, the patient will be returned to the supine position. The sevoflurane will be discontinued and the airway device will be removed when the anesthesiologist deems it appropriate. Prior to leaving the OR, the anesthesiologist may give pain or anti-anxiety medicine as needed.
- Postoperative: All patients will receive routine PACU care. Pain and anxiety scores will be recorded according to routine PACU practice. Medication for pain, nausea, and anxiety will be given according to the judgment of the anesthesiologist.
- Measured end-points:
- Time from induction of anesthesia to placement of the airway device ii. Time from end of procedure to arrival in the PACU iii. Time spent in the PACU iv. Overall time from arrival in the OR to discharge home v. Vomiting after the procedure vi. Nausea requiring medicine after the procedure vii. Lowest oxygen saturation level during or after the procedure viii. Highest concentration of sevoflurane during the procedure ix. Highest pain level after the procedure x. Amount of pain medicine given xi. Adverse events xii. Satisfaction level of the doctor doing the EGD
- Conditions
- Airway Morbidity
- Being tested
- LMA, ETT
- Keywords
- Airway management comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMADevice
Patients randomized to the LMA group had their airways maintained with a LMA device
ETTDevice
Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital
| Study group | Role | What they receive |
|---|---|---|
| Largyngeal Mask Airway for EGD procedure | Experimental | Patients randomized to LMA to maintain airway through EGD procedure Receives: Device: LMA |
| Endotracheal Tube for EGD procedure | Active comparator | Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital Receives: Device: ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopist Satisfaction
Endoscopist was surveyed to determine their satisfaction with each of the airway devices.
Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:
- The airway device did not interfere at all with the ability to perform the scope.
- The airway device presented some interference with the scope, but not enough to cause difficulty.
- The airway device made it difficult to perform the endoscopy.
- The airway device prevented the endoscopy from being performed.
Measured: 2 hours
Secondary outcomes (1)
OR to Discharge (Min)
Overall time from arrival in the OR to discharge home (in minutes)
Measured: OR to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionFeb 2013
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 Airway MorbidityStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Micahel Acquaviva, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936662
- Sponsor's protocol ID
- 1011002885
- Status last verified
- Apr 2016
- First submitted
- 29 Aug 2013
- Last updated
- 2 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Acquaviva MA, Horn ND, Gupta SK. Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):54-6. doi: 10.1097/MPG.0000000000000348.
PubMed 24637966
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Intubation vs. Laryngeal Mask Airway for Esophagogastroduodenoscopy in Children
- ClinicalTrials.gov ID
- NCT01936662
- Acronym / sponsor ID
- 1011002885
- Conditions
- Airway Morbidity
- Keywords
- Airway management comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 2 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or without associated biopsies, is relatively short in length. Unlike adults, who regularly undergo this procedure with conscious sedation, children most often require general anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children for EGD can result in delayed awakening and slow room turnover, particularly when intravenous medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to intubation, which permits removal before full awakening.
Although considered a safe alternative to tracheal intubation in appropriate cases, disadvantages of the LMA have been reported including kinking, occluding view of the surgical field, failure of placement requiring tracheal intubation, aspiration of gastric contents, desaturation, and laryngospasm. The study was designed to determine whether use of an LMA for EGD could reduce operating room time, while providing satisfactory conditions for the endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise healthy children with gastrointestinal complaints
Detailed description
- Study design The study will be randomized, controlled, and prospective in design.
- Comparison groups The two comparison groups will be:
- Laryngeal Mask Airway Group (LMA), N = 42 LMA will be used as the intraoperative airway device.
- Endotracheal Tube Group (ETT), N = 42 ETT will be used as the intraoperative airway device.
- Study and timeline of interventions
- Preoperative: All patients enrolled in this study will receive a standard preoperative dose of oral midazolam 0.5 mg/kg up to 15 mg, 15 to 30 minutes prior to anesthetic induction.
- Intraoperative: Subjects will all undergo induction of anesthesia by inhalation of sevoflurane and oxygen. An intravenous catheter (IV) will be placed, followed by lidocaine 2mg/kg IV. The airway device will be placed (LMA or ETT). As required for the procedure, the subject will be placed in a left lateral decubitus (left side down) position. Maintenance of anesthesia will be provided with sevoflurane at a concentration of 1.5-2 MAC, or higher if deemed appropriate for the clinical setting as judged by the anesthesiologist. All participants will be given the anti-nausea medicine ondansetron 0.1mg/kg (maximum 4 mg) after placement of the airway device. When the endoscope is removed at the completion of the procedure, the patient will be returned to the supine position. The sevoflurane will be discontinued and the airway device will be removed when the anesthesiologist deems it appropriate. Prior to leaving the OR, the anesthesiologist may give pain or anti-anxiety medicine as needed.
- Postoperative: All patients will receive routine PACU care. Pain and anxiety scores will be recorded according to routine PACU practice. Medication for pain, nausea, and anxiety will be given according to the judgment of the anesthesiologist.
- Measured end-points:
- Time from induction of anesthesia to placement of the airway device ii. Time from end of procedure to arrival in the PACU iii. Time spent in the PACU iv. Overall time from arrival in the OR to discharge home v. Vomiting after the procedure vi. Nausea requiring medicine after the procedure vii. Lowest oxygen saturation level during or after the procedure viii. Highest concentration of sevoflurane during the procedure ix. Highest pain level after the procedure x. Amount of pain medicine given xi. Adverse events xii. Satisfaction level of the doctor doing the EGD
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Largyngeal Mask Airway for EGD procedure | Experimental | Device: LMAPatients randomized to LMA to maintain airway through EGD procedure |
| Endotracheal Tube for EGD procedure | Active comparator | Device: ETTPatients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Scheduled for Esophagogastroduodenoscopy, with or without biopsies
- Have been informed of the nature of the study and informed consent has been obtained from the legally responsible
- Have provided assent in accordance with Institutional Review Board requirements
- Are able to complete pain assessment evaluations as determined by preoperative evaluations
Key exclusion criteria (9 listed)
- • Abnormal/difficult airway
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 |
|---|---|---|
| LMAPatients randomized to the LMA group had their airways maintained with a LMA device | Device | Largyngeal Mask Airway for EGD procedure |
| ETTPatients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital | Device | Endotracheal Tube for EGD procedure |
Primary outcome
Endoscopist Satisfaction
Time frame: 2 hours
Endoscopist was surveyed to determine their satisfaction with each of the airway devices. Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used: 1. The airway device did not interfere at all with the ability to perform the scope. 2. The airway device presented some interference with the scope, but not enough to cause difficulty. 3. The airway device made it difficult to perform the endoscopy. 4. The airway device prevented the endoscopy from being performed.
1 secondary outcome
OR to Discharge (Min)
Time frame: OR to discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24637966Acquaviva MA, Horn ND, Gupta SK. Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):54-6. doi: 10.1097/MPG.0000000000000348.
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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.
Micahel Acquaviva, MD principal investigator
Indiana 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 LMA and ETT in people with Airway Morbidity, run by Indiana 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 4 inclusion and 9 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 2 May 2016. 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 2 May 2016). 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?
Endoscopist Satisfaction (time frame: 2 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 NCT01936662, 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 2 May 2016.