Difficult IntubationNCT02944305
A Predictive Model for Difficult Intubation
An observational study of Difficult Intubation, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 7,500 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing general anesthesia with endotracheal intubation
Who may be able to join
- Adult patients undergoing general anesthesia with endotracheal intubation
Who cannot join
- Incomplete airway assessment in medical record
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: A New Prognostic Model Developed by Using Multi-predictive Tests for Prediction of Difficult Intubation in Adult Anesthetic Patients
Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.
Read the detailed description
Objective: To develop a scoring model from multiple airway assessment to predict difficult intubation.
Methods: This will be a retrospective analytic study. All airway assessment data from medical records of patients aged more than 18 years old underwent general anesthesia in Srinagarind hospital from January 2012 to December 2014 will be used to develop a new scoring prediction model.
- Conditions
- Difficult Intubation
- Being tested
- Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
Endotracheal intubation under direct laryngoscopy using McIntosh blade
| Study group | Role | What they receive |
|---|---|---|
| Patient with difficult intubation | Group 1: Patient undergoing endotracheal intubation with difficult intubation Group 2: Patient undergoing endotracheal intubation without difficult intubation Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult intubation
Laryngoscopic view: grade 1-2 = no difficult intubation; grade 3-4 = difficult intubation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- Retrospective
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, Principal investigator, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944305
- Sponsor's protocol ID
- HE581149
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PubMed 9416711Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.
PubMed 11207469Aktas S, Atalay YO, Tugrul M. Predictive value of bedside tests for difficult intubations. Eur Rev Med Pharmacol Sci. 2015;19(9):1595-9.
PubMed 26004598Iohom G, Ronayne M, Cunningham AJ. Prediction of difficult tracheal intubation. Eur J Anaesthesiol. 2003 Jan;20(1):31-6. doi: 10.1017/s0265021503000061.
PubMed 12553386Merah NA, Foulkes-Crabbe DJ, Kushimo OT, Ajayi PA. Prediction of difficult laryngoscopy in a population of Nigerian obstetric patients. West Afr J Med. 2004 Jan-Mar;23(1):38-41. doi: 10.4314/wajm.v23i1.28079.
PubMed 15171524
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Prognostic Model Developed by Using Multi-predictive Tests for Prediction of Difficult Intubation in Adult Anesthetic Patients
- ClinicalTrials.gov ID
- NCT02944305
- Acronym / sponsor ID
- HE581149
- Conditions
- Difficult Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Oct 2016 (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.
Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.
Detailed description
Objective: To develop a scoring model from multiple airway assessment to predict difficult intubation.
Methods: This will be a retrospective analytic study. All airway assessment data from medical records of patients aged more than 18 years old underwent general anesthesia in Srinagarind hospital from January 2012 to December 2014 will be used to develop a new scoring prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with difficult intubation | – | Procedure: Endotracheal intubationGroup 1: Patient undergoing endotracheal intubation with difficult intubation Group 2: Patient undergoing endotracheal intubation without difficult intubation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing general anesthesia with endotracheal intubation
Key inclusion criteria (1 listed)
- Adult patients undergoing general anesthesia with endotracheal intubation
Key exclusion criteria (1 listed)
- Incomplete airway assessment in medical record
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 |
|---|---|---|
| Endotracheal intubationEndotracheal intubation under direct laryngoscopy using McIntosh blade | Procedure or surgery | Patient with difficult intubation |
Primary outcome
Difficult intubation
Time frame: 5 minutes
Laryngoscopic view: grade 1-2 = no difficult intubation; grade 3-4 = difficult intubation
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 3 Mar 2017.
- Results publication: PubMed 9416711Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Results publication: PubMed 11207469Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.
- Results publication: PubMed 26004598Aktas S, Atalay YO, Tugrul M. Predictive value of bedside tests for difficult intubations. Eur Rev Med Pharmacol Sci. 2015;19(9):1595-9.
- Results publication: PubMed 12553386Iohom G, Ronayne M, Cunningham AJ. Prediction of difficult tracheal intubation. Eur J Anaesthesiol. 2003 Jan;20(1):31-6. doi: 10.1017/s0265021503000061.
- Results publication: PubMed 15171524Merah NA, Foulkes-Crabbe DJ, Kushimo OT, Ajayi PA. Prediction of difficult laryngoscopy in a population of Nigerian obstetric patients. West Afr J Med. 2004 Jan-Mar;23(1):38-41. doi: 10.4314/wajm.v23i1.28079.
- Individual participant dataSharing planned: No
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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.
Sirirat Tribuddharat, MD principal investigator
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
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 Difficult Intubation, run by Khon Kaen 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 1 inclusion and 1 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 3 Mar 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?
Difficult intubation (time frame: 5 minutes). 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 NCT02944305, which also lists 5 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 3 Mar 2017.