Difficult Intubation, Tongue MobilityNCT02679027
Difficult Intubation and Tongue Protrusion
A study testing Protrude tongue maximally and upward (PTMU) and Protrude tongue maximally and downward (PTMD) in people with Difficult Intubation, Tongue Mobility, run by Trakya University.
Trial summary
Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation. Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Difficult Intubation, Tongue Mobility
- What is being tested?
- Protrude tongue maximally and upward (PTMU) and Protrude tongue maximally and downward (PTMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Who cannot join
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
About this study
Official title: New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.
Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.
To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.
- Conditions
- Difficult Intubation, Tongue Mobility
- Being tested
- Protrude tongue maximally and upward (PTMU), Protrude tongue maximally and downward (PTMD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protrude tongue maximally and upward (PTMU)Other
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).
Protrude tongue maximally and downward (PTMD)Other
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).
| Study group | Role | What they receive |
|---|---|---|
| Easy intubation | Active comparator | Intubation difficulty score <5 Receives: Other: Protrude tongue maximally and upward (PTMU); Other: Protrude tongue maximally and downward (PTMD) |
| Difficult intubation | Active comparator | Intubation difficulty score >5 Receives: Other: Protrude tongue maximally and upward (PTMU); Other: Protrude tongue maximally and downward (PTMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation difficulty scale
Intubation difficulty scale score includes 7 variables for difficult intubation. N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point). A score of 0-4 defines easy intubation and an IDS score ≥5 defines difficult intubation
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Intubation, Tongue MobilityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alkin Colak, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679027
- Sponsor's protocol ID
- tongueintubation
- Status last verified
- Aug 2016
- First submitted
- 27 Jan 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
- ClinicalTrials.gov ID
- NCT02679027
- Acronym / sponsor ID
- tongueintubation
- Conditions
- Difficult Intubation, Tongue Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Feb 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.
Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.
Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.
To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Easy intubation | Active comparator | Other: Protrude tongue maximally and upward (PTMU), Other: Protrude tongue maximally and downward (PTMD)Intubation difficulty score <5 |
| Difficult intubation | Active comparator | Other: Protrude tongue maximally and upward (PTMU), Other: Protrude tongue maximally and downward (PTMD)Intubation difficulty score >5 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Key exclusion criteria (4 listed)
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
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 |
|---|---|---|
| Protrude tongue maximally and upward (PTMU)The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU). | Other | Difficult intubation, Easy intubation |
| Protrude tongue maximally and downward (PTMD)The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD). | Other | Difficult intubation, Easy intubation |
Primary outcome
Intubation difficulty scale
Time frame: 2 days
Intubation difficulty scale score includes 7 variables for difficult intubation. N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point). A score of 0-4 defines easy intubation and an IDS score ≥5 defines 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 16 Aug 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Protrude tongue maximally and upward (PTMU) and Protrude tongue maximally and downward (PTMD) in people with Difficult Intubation, Tongue Mobility, run by Trakya University.
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 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 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Intubation difficulty scale (time frame: 2 days). 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 16 Aug 2016.