Intubation; Difficult or FailedNCT03013036
Ultrasonography for Prediction of Difficult Intubation and Prediction of Endotracheal Tube Size
A study testing Ultrasonography, Sevoflurane and intravenous midazolam in people with Intubation; Difficult or Failed, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Ultrasonography, Sevoflurane and intravenous midazolam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Dec 2017
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 1 and 8 years
- Elective surgery
Who cannot join
- Patients with head or neck abnormalities
- Syndromic patients
- Emergency surgery and patients with a
- History of difficult airway
- Allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Fatih, 34098
Fatis Altindas, M.D., 00905337785278, fatisaltindas@hotmail.com
About this study
Official title: Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size
Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.
Read the detailed description
After ethics committee approval and parental consent were obtained, 119 patients undergoing genitourinary surgery or inguinal hernia repair under general anesthesia, were included in study. Patients with head or neck anomalies, syndromic patients, patients undergoing emergency surgery and patients with a history of difficult airway were excluded from the study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5 years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following sevoflurane induction in groups I and II. In group III, USG measurements were performed following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic and subglottic diameters were measured with ultrasonography. The size of the endotracheal tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5 mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration , Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of age related formula and Bae 's formula, only patients who were intubated with un-cuffed endotracheal tube were evaluated.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Ultrasonography, Sevoflurane, intravenous midazolam, Propofol, fentanyl and rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
SevofluraneDrug
intravenous midazolamDrug
PropofolDrug
fentanyl and rocuroniumDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I | Other | Patients between 1 and 2 years Receives: Device: Ultrasonography; Drug: Sevoflurane; Drug: intravenous midazolam; Drug: fentanyl and rocuronium |
| Group II | Other | patients between 3 and 5 years Receives: Device: Ultrasonography; Drug: Sevoflurane; Drug: Propofol; Drug: fentanyl and rocuronium |
| Group III | Other | patients between 6 and 8 years Receives: Device: Ultrasonography; Drug: Sevoflurane; Drug: intravenous midazolam; Drug: fentanyl and rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance
Measured: three years
Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startFeb 2013
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Aybike Ozmumcu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013036
- Sponsor's protocol ID
- 0964
- Status last verified
- Jan 2017
- First submitted
- 27 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size
- ClinicalTrials.gov ID
- NCT03013036
- Acronym / sponsor ID
- 0964
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (estimated)
- First posted
- 6 Jan 2017 (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.
Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.
Detailed description
After ethics committee approval and parental consent were obtained, 119 patients undergoing genitourinary surgery or inguinal hernia repair under general anesthesia, were included in study. Patients with head or neck anomalies, syndromic patients, patients undergoing emergency surgery and patients with a history of difficult airway were excluded from the study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5 years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following sevoflurane induction in groups I and II. In group III, USG measurements were performed following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic and subglottic diameters were measured with ultrasonography. The size of the endotracheal tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5 mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration , Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of age related formula and Bae 's formula, only patients who were intubated with un-cuffed endotracheal tube were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Other | Device: Ultrasonography, Drug: Sevoflurane, Drug: intravenous midazolam, Drug: fentanyl and rocuroniumPatients between 1 and 2 years |
| Group II | Other | Device: Ultrasonography, Drug: Sevoflurane, Drug: Propofol, Drug: fentanyl and rocuroniumpatients between 3 and 5 years |
| Group III | Other | Device: Ultrasonography, Drug: Sevoflurane, Drug: intravenous midazolam, Drug: fentanyl and rocuroniumpatients between 6 and 8 years |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged between 1 and 8 years
- Elective surgery
Key exclusion criteria (5 listed)
- Patients with head or neck abnormalities
- Syndromic patients
- Emergency surgery and patients with a
- History of difficult airway
- Allergy to ultrasound gel
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 |
|---|---|---|
| Ultrasonography | Device | Group I, Group II, Group III |
| Sevoflurane | Drug | Group I, Group II, Group III |
| intravenous midazolam | Drug | Group I, Group III |
| Propofol | Drug | Group II |
| fentanyl and rocuronium | Drug | Group I, Group II, Group III |
Primary outcome
Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance
Time frame: three years
Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography, Sevoflurane and intravenous midazolam in people with Intubation; Difficult or Failed, run by Istanbul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif A Ozmumcu, M.D. (00905332934202, elfaybike@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance (time frame: three years). The study lists 2 primary outcomes in all. 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 6 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.