Difficult / Failed IntubationNCT05735106
NC/TMD Ratio As a Difficult Airway Predictor in Obese Patients
An observational study of Difficult / Failed Intubation, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial summary
To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult / Failed Intubation
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Oct 2021to 21 May 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese patients (BMI ≥30Kg/m2) of all genders, between age of 18 to 65 years, belonging to ASA class I-III, Undergoing elective surgery under general anesthesia
Who may be able to join
- ASA physical status I to III
- Body Mass Index (BMI) of 30kg/m2 or more
- age 18-65 years
Who cannot join
- non consenting
- ASA class greater than III,
- patients undergoing general anesthesia without tracheal intubation or under regional anesthesia,
- patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neck Circumference to Thyromental Distance Ratio As a Reliable Indicator for Predicting Difficult Intubation in Obese Patients for Elective Surgery Under General Anesthesia
To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard.
Read the detailed description
At Preanaesthesia clinic patients , neck circumference to Thyromental distance ratios of obese patients with BMI >30Kg/m2 will be calculated and patients will be divided into two groups on the basis of Nc/TMD ratio as anticipated easy intubation ( NC/TMD<5) And anticipated difficult intubation ( NC/TMD ≥5).
Intra-operatively, patients Intubation difficulty scale score will calculated and the data obtained from IDS score will be compared with NC/TMD ratio as a predictor of difficult Intubation and diagnostic accuracy of NC/TMD as a reliable indicator of difficult intubation in obese patients will be calculated by statistical analysis.
- Conditions
- Difficult / Failed Intubation
- Keywords
- difficult intubation, NC/TM distance ratio, intubation difficulty score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (predicted easy intubation) | Group A labelled as predicted easy intubation on the basis of NC/TM distance ratio <5 | |
| Group B (predicted difficult intubation) | Group B labelled as predicted Difficult intubation on the basis of NC/TM distance ratio ≥ 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictability of difficult airway
At the preanaesthetic examination neck circumference to thyromental distance ratio will be caculated in obese patients with BMI ≥ 30KG/m2 and the predictability of difficult airway will be evaluated by statistical analysis
Measured: During anaesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start21 Oct 2021
- Primary completion21 Apr 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult / Failed 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
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahnoor Shabbir, KRL Hospital, Islamabad
- Investigators
- Mahnoor Shabbir, Principal investigator, KrlH Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735106
- Sponsor's protocol ID
- NC/TMD1
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Circumference to Thyromental Distance Ratio As a Reliable Indicator for Predicting Difficult Intubation in Obese Patients for Elective Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05735106
- Acronym / sponsor ID
- NC/TMD1
- Conditions
- Difficult / Failed Intubation
- Keywords
- difficult intubation, NC/TM distance ratio, intubation difficulty score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 21 Feb 2023 (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.
To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard.
Detailed description
At Preanaesthesia clinic patients , neck circumference to Thyromental distance ratios of obese patients with BMI >30Kg/m2 will be calculated and patients will be divided into two groups on the basis of Nc/TMD ratio as anticipated easy intubation ( NC/TMD<5) And anticipated difficult intubation ( NC/TMD ≥5).
Intra-operatively, patients Intubation difficulty scale score will calculated and the data obtained from IDS score will be compared with NC/TMD ratio as a predictor of difficult Intubation and diagnostic accuracy of NC/TMD as a reliable indicator of difficult intubation in obese patients will be calculated by statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (predicted easy intubation) | – | –Group A labelled as predicted easy intubation on the basis of NC/TM distance ratio <5 |
| Group B (predicted difficult intubation) | – | –Group B labelled as predicted Difficult intubation on the basis of NC/TM distance ratio ≥ 5 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients (BMI ≥30Kg/m2) of all genders, between age of 18 to 65 years, belonging to ASA class I-III, Undergoing elective surgery under general anesthesia
Key inclusion criteria (3 listed)
- ASA physical status I to III
- Body Mass Index (BMI) of 30kg/m2 or more
- age 18-65 years
Key exclusion criteria (4 listed)
- non consenting
- ASA class greater than III,
- patients undergoing general anesthesia without tracheal intubation or under regional anesthesia,
- patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictability of difficult airway
Time frame: During anaesthesia induction
At the preanaesthetic examination neck circumference to thyromental distance ratio will be caculated in obese patients with BMI ≥ 30KG/m2 and the predictability of difficult airway will be evaluated by statistical analysis
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 10 Oct 2024.
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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.
Mahnoor Shabbir principal investigator
KrlH Islamabad
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 / Failed Intubation, run by KRL Hospital, Islamabad at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 10 Oct 2024. 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 Pakistan. 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?
Predictability of difficult airway (time frame: During anaesthesia induction). 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 10 Oct 2024.