Anesthesia Intubation ComplicationNCT02461017
Endotracheal Tube Audible Leak Test
An observational study of Anesthesia Intubation Complication and Mechanical Ventilation Complication, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Anesthesia Intubation Complication, Mechanical Ventilation Complication
- What is being tested?
- Assess for Audible Endotracheal Leak and Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2015to 21 Feb 2017
- Phase
- Observational
- 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 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.
Who may be able to join
- Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.
Who cannot join
- Known history of subglottic stenosis
- Known history of recurrent croup
- Known history of endolaryngeal or subglottic lesions
- Parents refusal of participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Endotracheal Tube Audible Leak Test: What is the Accuracy?
The endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.
Read the detailed description
The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.
- Being tested
- Assess for Audible Endotracheal Leak, Assess for Endotracheal Leak with direct visualization under rigid bronchoscope
- Keywords
- intubation, ventilation, airway, airleak
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess for Audible Endotracheal LeakOther
In supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded.
Assess for Endotracheal Leak with direct visualization under rigid bronchoscopeOther
In the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Leak | Assess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope Receives: Other: Assess for Audible Endotracheal Leak; Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak
Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet.
Measured: one year.
Secondary outcomes (1)
Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's
Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's.
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 posted3 Jun 2015 (estimated)
- Study start7 Dec 2015
- Primary completion9 Jan 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Intubation ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhankumar Sathyamoorthy, University of Mississippi Medical Center
- Investigators
- Madhankumar Sathyamoorthy, MBBS, MS, Principal investigator, Univeristy of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461017
- Sponsor's protocol ID
- 2015-0164
- Status last verified
- Jun 2017
- First submitted
- 28 May 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suominen P, Taivainen T, Tuominen N, Voipio V, Wirtavuori K, Hiller A, Korpela R, Karjalainen T, Meretoja O. Optimally fitted tracheal tubes decrease the probability of postextubation adverse events in children undergoing general anesthesia. Paediatr Anaesth. 2006 Jun;16(6):641-7. doi: 10.1111/j.1460-9592.2005.01832.x.
PubMed 16719880Finholt DA, Henry DB, Raphaely RC. Factors affecting leak around tracheal tubes in children. Can Anaesth Soc J. 1985 Jul;32(4):326-9. doi: 10.1007/BF03011335.
PubMed 4027762Schwartz RE, Stayer SA, Pasquariello CA. Tracheal tube leak test--is there inter-observer agreement? Can J Anaesth. 1993 Nov;40(11):1049-52. doi: 10.1007/BF03009476.
PubMed 8269566
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Audible Leak Test: What is the Accuracy?
- ClinicalTrials.gov ID
- NCT02461017
- Acronym / sponsor ID
- 2015-0164
- Keywords
- intubation, ventilation, airway, airleak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 3 Jun 2015 (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 endotracheal tube (ETT) leak test (LT), or audible leak test is a widely performed assessment to verify appropriate tube size in neonates, infants and children. However, many factors are known to influence the audible leak test. Even though the test is widely performed, the accuracy has not been evaluated.
Detailed description
The endotracheal tube (ETT) leak test (LT), or audible leak when the peak airway pressures reach 15-30 cmH2O, is a commonly performed assessment to confirm that an endotracheal tube size is appropriate for a child in order to minimize the risk of airway injury and adverse events after removal of ETT. Many factors are known to affect the results of the leak test and variation in results among experienced anesthesiologists may be as great as 38%, but the accuracy of the audible leak test by directly observing the presence of a leak around the ETT has not been evaluated. This study will attempt to use direct visualization of the air leak to correlate to and assess the accuracy of the audible air leak test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Leak | – | Other: Assess for Audible Endotracheal Leak, Other: Assess for Endotracheal Leak with direct visualization under rigid bronchoscopeAssess for Audible Endotracheal Leak; Assess for Endotracheal Leak with direct visualization under rigid bronchoscope |
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.
Key inclusion criteria (1 listed)
- Children aged between 1 month (post-natal) and 8 years scheduled for ENT surgery requiring general anesthesia with an endotracheal tube.
Key exclusion criteria (4 listed)
- Known history of subglottic stenosis
- Known history of recurrent croup
- Known history of endolaryngeal or subglottic lesions
- Parents refusal of participation in study
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 |
|---|---|---|
| Assess for Audible Endotracheal LeakIn supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded. | Other | Endotracheal Leak |
| Assess for Endotracheal Leak with direct visualization under rigid bronchoscopeIn the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study. | Other | Endotracheal Leak |
Primary outcome
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak
Time frame: one year.
Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak using a flexible nasal laryngoscope positioned superior to the laryngeal inlet.
1 secondary outcome
Secondary Objective Evidence suggesting a relationship between the presence of an audible leak and direct visualization for cuffed and uncuffed TT's
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 2 Jul 2017.
- Background: PubMed 16719880Suominen P, Taivainen T, Tuominen N, Voipio V, Wirtavuori K, Hiller A, Korpela R, Karjalainen T, Meretoja O. Optimally fitted tracheal tubes decrease the probability of postextubation adverse events in children undergoing general anesthesia. Paediatr Anaesth. 2006 Jun;16(6):641-7. doi: 10.1111/j.1460-9592.2005.01832.x.
- Background: PubMed 4027762Finholt DA, Henry DB, Raphaely RC. Factors affecting leak around tracheal tubes in children. Can Anaesth Soc J. 1985 Jul;32(4):326-9. doi: 10.1007/BF03011335.
- Background: PubMed 8269566Schwartz RE, Stayer SA, Pasquariello CA. Tracheal tube leak test--is there inter-observer agreement? Can J Anaesth. 1993 Nov;40(11):1049-52. doi: 10.1007/BF03009476.
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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.
Madhankumar Sathyamoorthy, MBBS, MS principal investigator
Univeristy of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Intubation Complication and Mechanical Ventilation Complication, run by University of Mississippi Medical Center 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 2 Jul 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?
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?
Primary Objective Evidence of an audible endotracheal leak and/or direct visualized endotracheal leak (time frame: one year.). 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 NCT02461017, which also lists 3 linked publications.
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 Jul 2017.