Difficult or Failed IntubationNCT05043779
Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation
A study testing Awake Airway Nasoendoscopy in people with Difficult or Failed Intubation and Obesity, Morbid, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Despite the availability of different methods for airway assessment, unexpectedly difficult intubations occur at a frequency of up to 15%. A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy and airway but their usefulness is limited in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult or Failed Intubation, Obesity, Morbid
- What is being tested?
- Awake Airway Nasoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteQatar
- Study dates
- 12 Aug 2020to 1 Mar 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients between 18-60 years of age either male or female with (ASA I, II or III ), scheduled for a bariatric procedure with a body mass index (BMI) greater than 35 K/M2, will be enrolled
Who cannot join
- Patients on the tracheostomy tube
- Patients who are unable to give consent
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
ACC, Hamad Medical Corporation
Doha, Doah, 3050
Nabil Shallik, M.D., 55439284, nshallik@outlook.com
Mohamed A. Elarref, M.D.
About this study
Official title: Is Preoperative Awake Airway Nasoendoscopy A Good Tool To Predict The Expected Difficult Airway In Obese Patients?
Despite the availability of different methods for airway assessment, unexpectedly difficult intubations occur at a frequency of up to 15%. A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy and airway but their usefulness is limited in obese patients.
Could awake invasive airway assessment be more predictive for difficult airways in obese patients? The use of nasendoscopy assessment for the airway could be a useful additional invasive tool to predict the difficult airway in obese
Read the detailed description
Predictors of difficult laryngoscopy and intubation may be less useful or irrelevant when there is a plan for video laryngoscopes (VL) intraoperative. VL improves laryngeal view in most patients, Their use achieves a high success rate for intubation of patients with predicted difficult intubation, and those who have failed direct laryngoscopy[6]. In a study of over 2000 (VL) video laryngoscopies intubations, Mallampati's score did not correlate with failed intubation. The strongest predictor of failure was neck pathology, including the presence of a surgical scar, radiation changes, or mass. In another study, risk factors for difficult VL intubation after direct laryngoscopy were Cormack-Lehane grade 3 or 4 views with direct laryngoscopy, short sternothyroid distance, and high upper lip bite test score. Obesity is a recognized risk factor for difficulty with airway management. An audit of major complications of airway management (NAP4) from over three million anesthetics in the United Kingdom found twice as many case reports of major complications in obese patients, especially in the morbidly obese.
It is less clear whether obesity increases the risk of difficult laryngoscopy or intubation. Some studies suggest that obesity is a risk factor for both difficult mask ventilation and difficult laryngoscopy, while other studies suggest that with proper positioning and preparation, ventilation and laryngoscopy are not difficult [12,13]. Wilson's score is an important development in predictivity of airway difficulties, Wilson's in his study (1988) attempted to deductively identify patients for whom intubation will be difficult.
This study aims to demonstrate the use of preoperative awake fibreoptic examination
- Conditions
- Difficult or Failed Intubation, Obesity, Morbid
- Being tested
- Awake Airway Nasoendoscopy
- Keywords
- Nasoendoscopy,, Obesity,, Difficult intubation
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake Airway NasoendoscopyProcedure or surgery
Preoperative Awake Airway Nasoendoscopy of upper airway
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Awake Airway Nasoendoscopy | Other | only one arm Receives: Procedure: Awake Airway Nasoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.
Findings will be recorded and scored according to NOHL (N=nose, O= oral, H= hypopharynx and L= Larynx ) every parameter takes a score from 1- 4 during pre-operative assessment.(the maximum values score = 16 and the minimum = 4)
Measured: During pre-operative assessment.
Secondary outcomes (5)
Measurement of neck circumference in Centimeter
This will be measured by centimeter during pre-operative assessment using a ruler
Measured: During pre-operative assessment.
Mouth opening measurement by Centimeter
This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter
Measured: During pre-operative assessment.
Thyro-mental distance measurement by Centimeter
This will be measured by centimeter from thyroid cartilage to patient's chin during pre-operative assessment using a rule
Measured: During pre-operative assessment.
Difficult mask ventilation score (1 -3)
Degree of Difficulty in mask ventilation will be graded (1= easy, 2= difficult or 3=impossible) during induction of general anaesthesia
Measured: During Induction of anesthesia
Cormak-Lehans grade during induction of anaesthesia
Cormak-Lehans Score will graded during endotracheal intubation and exposure of the larynx. (Grade 1= easy intubation while grade Grade 4= very difficult intubation)
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start12 Aug 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Difficult or Failed IntubationStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nabil Shallik, M.D., Principal investigator, Hamad Medical Corporation - HMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043779
- Sponsor's protocol ID
- MRC-01-19-107
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share after IRB approval
Publications
Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.
PubMed 1595845Janssens M, Hartstein G. Management of difficult intubation. Eur J Anaesthesiol. 2001 Jan;18(1):3-12. doi: 10.1046/j.0265-0215.2000.00777.x.
PubMed 11270007Qudaisat IY, Al-Ghanem SM. Short thyromental distance is a surrogate for inadequate head extension, rather than small submandibular space, when indicating possible difficult direct laryngoscopy. Eur J Anaesthesiol. 2011 Aug;28(8):600-6. doi: 10.1097/EJA.0b013e328347cdd9.
PubMed 21610502Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
PubMed 10781266Tremblay MH, Williams S, Robitaille A, Drolet P. Poor visualization during direct laryngoscopy and high upper lip bite test score are predictors of difficult intubation with the GlideScope videolaryngoscope. Anesth Analg. 2008 May;106(5):1495-500, table of contents. doi: 10.1213/ane.0b013e318168b38f.
PubMed 18420866Samsoon GL, Young JR. Difficult tracheal intubation: a retrospective study. Anaesthesia. 1987 May;42(5):487-90. doi: 10.1111/j.1365-2044.1987.tb04039.x.
PubMed 3592174Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.
PubMed 15567809Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.
PubMed 19194154Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.
PubMed 22340664Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
PubMed 15527629Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.
PubMed 11867407Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.
PubMed 3415893Vicini C, De Vito A, Benazzo M, Frassineti S, Campanini A, Frasconi P, Mira E. The nose oropharynx hypopharynx and larynx (NOHL) classification: a new system of diagnostic standardized examination for OSAHS patients. Eur Arch Otorhinolaryngol. 2012 Apr;269(4):1297-300. doi: 10.1007/s00405-012-1965-z. Epub 2012 Feb 19.
PubMed 22350494Soares MC, Sallum AC, Goncalves MT, Haddad FL, Gregorio LC. Use of Muller's maneuver in the evaluation of patients with sleep apnea--literature review. Braz J Otorhinolaryngol. 2009 May-Jun;75(3):463-6. doi: 10.1016/S1808-8694(15)30667-4.
PubMed 19649500
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Awake Airway Nasoendoscopy A Good Tool To Predict The Expected Difficult Airway In Obese Patients?
- ClinicalTrials.gov ID
- NCT05043779
- Acronym / sponsor ID
- MRC-01-19-107
- Conditions
- Difficult or Failed Intubation, Obesity, Morbid
- Keywords
- Nasoendoscopy,, Obesity,, Difficult intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 14 Sep 2021 (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.
Despite the availability of different methods for airway assessment, unexpectedly difficult intubations occur at a frequency of up to 15%. A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy and airway but their usefulness is limited in obese patients.
Could awake invasive airway assessment be more predictive for difficult airways in obese patients? The use of nasendoscopy assessment for the airway could be a useful additional invasive tool to predict the difficult airway in obese
Detailed description
Predictors of difficult laryngoscopy and intubation may be less useful or irrelevant when there is a plan for video laryngoscopes (VL) intraoperative. VL improves laryngeal view in most patients, Their use achieves a high success rate for intubation of patients with predicted difficult intubation, and those who have failed direct laryngoscopy[6]. In a study of over 2000 (VL) video laryngoscopies intubations, Mallampati's score did not correlate with failed intubation. The strongest predictor of failure was neck pathology, including the presence of a surgical scar, radiation changes, or mass. In another study, risk factors for difficult VL intubation after direct laryngoscopy were Cormack-Lehane grade 3 or 4 views with direct laryngoscopy, short sternothyroid distance, and high upper lip bite test score. Obesity is a recognized risk factor for difficulty with airway management. An audit of major complications of airway management (NAP4) from over three million anesthetics in the United Kingdom found twice as many case reports of major complications in obese patients, especially in the morbidly obese.
It is less clear whether obesity increases the risk of difficult laryngoscopy or intubation. Some studies suggest that obesity is a risk factor for both difficult mask ventilation and difficult laryngoscopy, while other studies suggest that with proper positioning and preparation, ventilation and laryngoscopy are not difficult [12,13]. Wilson's score is an important development in predictivity of airway difficulties, Wilson's in his study (1988) attempted to deductively identify patients for whom intubation will be difficult.
This study aims to demonstrate the use of preoperative awake fibreoptic examination
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Awake Airway Nasoendoscopy | Other | Procedure: Awake Airway Nasoendoscopyonly one arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients between 18-60 years of age either male or female with (ASA I, II or III ), scheduled for a bariatric procedure with a body mass index (BMI) greater than 35 K/M2, will be enrolled
Key exclusion criteria (2 listed)
- Patients on the tracheostomy tube
- Patients who are unable to give consent
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 |
|---|---|---|
| Awake Airway NasoendoscopyPreoperative Awake Airway Nasoendoscopy of upper airway | Procedure or surgery | Preoperative Awake Airway Nasoendoscopy |
Primary outcome
Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.
Time frame: During pre-operative assessment.
Findings will be recorded and scored according to NOHL (N=nose, O= oral, H= hypopharynx and L= Larynx ) every parameter takes a score from 1- 4 during pre-operative assessment.(the maximum values score = 16 and the minimum = 4)
5 secondary outcomes
Measurement of neck circumference in Centimeter
Time frame: During pre-operative assessment.
Mouth opening measurement by Centimeter
Time frame: During pre-operative assessment.
Thyro-mental distance measurement by Centimeter
Time frame: During pre-operative assessment.
Difficult mask ventilation score (1 -3)
Time frame: During Induction of anesthesia
Cormak-Lehans grade during induction of anaesthesia
Time frame: During intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Results publication: PubMed 1595845Butler PJ, Dhara SS. Prediction of difficult laryngoscopy: an assessment of the thyromental distance and Mallampati predictive tests. Anaesth Intensive Care. 1992 May;20(2):139-42. doi: 10.1177/0310057X9202000202.
- Results publication: PubMed 11270007Janssens M, Hartstein G. Management of difficult intubation. Eur J Anaesthesiol. 2001 Jan;18(1):3-12. doi: 10.1046/j.0265-0215.2000.00777.x.
- Results publication: PubMed 21610502Qudaisat IY, Al-Ghanem SM. Short thyromental distance is a surrogate for inadequate head extension, rather than small submandibular space, when indicating possible difficult direct laryngoscopy. Eur J Anaesthesiol. 2011 Aug;28(8):600-6. doi: 10.1097/EJA.0b013e328347cdd9.
- Results publication: PubMed 10781266Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
- Results publication: PubMed 18420866Tremblay MH, Williams S, Robitaille A, Drolet P. Poor visualization during direct laryngoscopy and high upper lip bite test score are predictors of difficult intubation with the GlideScope videolaryngoscope. Anesth Analg. 2008 May;106(5):1495-500, table of contents. doi: 10.1213/ane.0b013e318168b38f.
- Results publication: PubMed 3592174Samsoon GL, Young JR. Difficult tracheal intubation: a retrospective study. Anaesthesia. 1987 May;42(5):487-90. doi: 10.1111/j.1365-2044.1987.tb04039.x.
- Results publication: PubMed 15567809Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.
- Results publication: PubMed 19194154Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.
- Results publication: PubMed 22340664Heinrich S, Birkholz T, Ihmsen H, Irouschek A, Ackermann A, Schmidt J. Incidence and predictors of difficult laryngoscopy in 11,219 pediatric anesthesia procedures. Paediatr Anaesth. 2012 Aug;22(8):729-36. doi: 10.1111/j.1460-9592.2012.03813.x. Epub 2012 Feb 20.
- Results publication: PubMed 15527629Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
- Results publication: PubMed 11867407Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.
- Results publication: PubMed 3415893Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.
- Individual participant dataSharing planned: Yes. We will share after IRB approval
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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.
Nabil Shallik, M.D. principal investigator
Hamad Medical Corporation - HMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake Airway Nasoendoscopy in people with Difficult or Failed Intubation and Obesity, Morbid, run by Hamad Medical Corporation at 1 site in Qatar.
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 2 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 14 Sep 2021. 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 Qatar. 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 nabil Shallik, M.D. (9745543926, nshallik@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment. (time frame: During pre-operative assessment.). 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 NCT05043779, which also lists 14 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 14 Sep 2021.