The Predictors of Difficult Intubation in Pediatric PatientsNCT04043767
Prognostic Factors for Difficult Intubation
An observational study of The Predictors of Difficult Intubation in Pediatric Patients, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- The Predictors of Difficult Intubation in Pediatric Patients
- What is being tested?
- Measurements of thyromental distances, hyomental distances and neck circumferences
- Type of treatment
- Surgery or procedure
- How many people
- 660 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2018to Feb 2021
- How long will I take part?
- 1 Day
- 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 year to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged between 1-8 years who schedule for elective surgery and having balance Anesthesia technique for surgery
Who may be able to join
- Pediatric patients aged between 1-8 years
- Schedule for elective surgery
- Having balance Anesthesia technique for surgery
Who cannot join
- Having aspiration risks
- Having history of difficult airway
- Abnormality of cervical spine /head and neck area
- Parental refusion
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ngamjit Pattaravit
Songkhla, 90110
Ngamjit Pattaravit, M.D., 66897001350, ngamjitp@yahoo.com
Maneemontra sunanand, M.D., 66849194975, hich_ice@hotmail.com
About this study
Official title: Prognostic Factors for Difficult Intubation in Pediatric Patients
Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. In this study, the investigator team want to identify the predictors of difficult intubation in pediatric patient by using additional parameters which are including hyomental distance, sternomental distance, neck circumference, ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance, Ratio of height to hyomental distance.
Read the detailed description
After approval from the instution's Ethics Committee, a prospective cohort study was conducted in pediatric patients aged between 1-8 years, ASA physical status I-II who were scheduled for general anesthesia in elective surgery. One day prior surgery, Children and their parents were invited to be participated in the study by using verbal invitation and flyer. After giving consent, Addition physical examinations which are the measurements of hyomental distance, sternomental distance and neck circumference were done by two independent investigators. The ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance and ratio of height to hyomental distance. At the day of surgery, standard general anesthesia (balance technique) was done. The child was intubated using aged appropriated laryngoscope by general anesthesiologist. Cormack-Lehane grading was used to identify the difficult intubation. (grade III and IV). Data will be analyzed by R Program. The statistically significance was set as P<0.05. Multivariate Logistic Regression analysis will be used to identify the predictors of difficult intubation.
- Being tested
- Measurements of thyromental distances, hyomental distances and neck circumferences
- Keywords
- predictors, difficult intubation, pediatric patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of thyromental distances, hyomental distances and neck circumferencesProcedure or surgery
thyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients aged between 1-8 years | Pediatric patients aged between 1-8 years who scheduled for general anesthesia in elective surgery. Additional physical examinations which were including thyromental distances, hyomental distances and neck circumferences, was performed at one day prior surgery. Intubation was done by general anesthesiologist in order to grade the laryngoscopic view. Receives: Procedure: Measurements of thyromental distances, hyomental distances and neck circumferences |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictors of difficult airway
Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation
Measured: up to 1 minutes after starting the process of intubation
Secondary outcomes (1)
The correlation between time spent for intubation and laryngoscopic view
Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation
Measured: up to 10 minutes after starting the process of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 May 2018
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Predictors of Difficult Intubation in Pediatric PatientsStudies 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
- 660 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Pattaravit, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043767
- Sponsor's protocol ID
- difficult airway
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Difficult Intubation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04043767
- Acronym / sponsor ID
- difficult airway
- Keywords
- predictors, difficult intubation, pediatric patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 2 Aug 2019 (actual)
- 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.
Difficult intubation is the situation that anesthesiologists don't want to face. Sometimes, difficult intubation affects the patient's oxygen saturation and harms for life. Many studies try to identify the predictors of difficult airway in pediatric patients. In this study, the investigator team want to identify the predictors of difficult intubation in pediatric patient by using additional parameters which are including hyomental distance, sternomental distance, neck circumference, ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance, Ratio of height to hyomental distance.
Detailed description
After approval from the instution's Ethics Committee, a prospective cohort study was conducted in pediatric patients aged between 1-8 years, ASA physical status I-II who were scheduled for general anesthesia in elective surgery. One day prior surgery, Children and their parents were invited to be participated in the study by using verbal invitation and flyer. After giving consent, Addition physical examinations which are the measurements of hyomental distance, sternomental distance and neck circumference were done by two independent investigators. The ratio of hyomental distance to Thyromental distance, ratio of hyomental distance to sternomental distance, ratio of height to neck circumference, ratio of height to thyromental distance and ratio of height to hyomental distance. At the day of surgery, standard general anesthesia (balance technique) was done. The child was intubated using aged appropriated laryngoscope by general anesthesiologist. Cormack-Lehane grading was used to identify the difficult intubation. (grade III and IV). Data will be analyzed by R Program. The statistically significance was set as P<0.05. Multivariate Logistic Regression analysis will be used to identify the predictors of difficult intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients aged between 1-8 years | – | Procedure: Measurements of thyromental distances, hyomental distances and neck circumferencesPediatric patients aged between 1-8 years who scheduled for general anesthesia in elective surgery. Additional physical examinations which were including thyromental distances, hyomental distances and neck circumferences, was performed at one day prior surgery. Intubation was done by general anesthesiologist in order to grade the laryngoscopic view. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged between 1-8 years who schedule for elective surgery and having balance Anesthesia technique for surgery
Key inclusion criteria (3 listed)
- Pediatric patients aged between 1-8 years
- Schedule for elective surgery
- Having balance Anesthesia technique for surgery
Key exclusion criteria (4 listed)
- Having aspiration risks
- Having history of difficult airway
- Abnormality of cervical spine /head and neck area
- Parental refusion
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 |
|---|---|---|
| Measurements of thyromental distances, hyomental distances and neck circumferencesthyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators. | Procedure or surgery | Pediatric patients aged between 1-8 years |
Primary outcome
The predictors of difficult airway
Time frame: up to 1 minutes after starting the process of intubation
Laryngoscopic view was determined by using Cormack-Lehane grading (grade III-IV) were used to identify difficult intubation situation
1 secondary outcome
The correlation between time spent for intubation and laryngoscopic view
Time frame: up to 10 minutes after starting the process of intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
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?
An observational study of The Predictors of Difficult Intubation in Pediatric Patients, run by Prince of Songkla University 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 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictors of difficult airway (time frame: up to 1 minutes after starting the process of intubation). 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 2 Aug 2019.