Pediatric General Anesthesia With Endotracheal TubeNCT02321956
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
A study testing Ultrasound in people with Pediatric General Anesthesia With Endotracheal Tube, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric General Anesthesia With Endotracheal Tube
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Mar 2016
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 1-6 Years
- ASA class 1-2
- Elective Surgery
- GA with oral uncuff endotracheal tube
Who cannot join
- Potential difficult air way from history and physical exam
- Allergy ti ultrasound gel
- neck mass
- unstable vital sign
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula
Read the detailed description
This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.
- Being tested
- Ultrasound
- Keywords
- ASA class 1,2, age 1-6 years, General anesthesia with ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Using ultrasound to determine the size of endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Using ultrasound measurement of the subglottic area to choose endotracheal tube size Receives: Diagnostic Test: Ultrasound |
| Formula | No intervention | Using Cole's formula to choose endotracheal tube size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper size of endotracheal tube
Clinically fit of endotracheal tube with leak at 20-25 cmH2O
Measured: 1 year
Secondary outcomes (1)
Correlation of subglottic diameter and proper size endotracheal tube
Correlation of subglottic diameter measured by ultrasound and proper size endotracheal tube determined by clinically fit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric General Anesthesia With Endotracheal TubeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raviwon Atisook, Siriraj Hospital
- Investigators
- Raviwon Atisook, Principal investigator, Department of anesthesiology siriraj hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321956
- Sponsor's protocol ID
- RAti-001
- Status last verified
- Jun 2017
- First submitted
- 17 Dec 2014
- Last updated
- 6 Jun 2017
- Results posted
- No
Publications
Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.
PubMed 20808208
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
- ClinicalTrials.gov ID
- NCT02321956
- Acronym / sponsor ID
- RAti-001
- Keywords
- ASA class 1,2, age 1-6 years, General anesthesia with ETT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Dec 2014 (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 purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula
Detailed description
This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Diagnostic Test: UltrasoundUsing ultrasound measurement of the subglottic area to choose endotracheal tube size |
| Formula | No intervention | –Using Cole's formula to choose endotracheal tube size |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 1-6 Years
- ASA class 1-2
- Elective Surgery
- GA with oral uncuff endotracheal tube
Key exclusion criteria (4 listed)
- Potential difficult air way from history and physical exam
- Allergy ti ultrasound gel
- neck mass
- unstable vital sign
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 |
|---|---|---|
| UltrasoundUsing ultrasound to determine the size of endotracheal tube | Diagnostic test | Ultrasound |
Primary outcome
Proper size of endotracheal tube
Time frame: 1 year
Clinically fit of endotracheal tube with leak at 20-25 cmH2O
1 secondary outcome
Correlation of subglottic diameter and proper size endotracheal tube
Time frame: 1 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 6 Jun 2017.
- Background: PubMed 20808208Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.
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.
Raviwon Atisook principal investigator
Department of anesthesiology siriraj hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Pediatric General Anesthesia With Endotracheal Tube, run by Siriraj Hospital at 1 site in Thailand.
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 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 6 Jun 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 Thailand. 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?
Proper size of endotracheal tube (time frame: 1 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 NCT02321956, 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 6 Jun 2017.