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Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

Primary Purpose

Difficult or Failed Intubation, Obesity, Morbid

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Awake Airway Nasoendoscopy
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Difficult or Failed Intubation focused on measuring Nasoendoscopy,, Obesity,, Difficult intubation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients on the tracheostomy tube
  • Patients who are unable to give consent

Sites / Locations

  • ACC, Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Preoperative Awake Airway Nasoendoscopy

Arm Description

only one arm

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Measurement of neck circumference in Centimeter
This will be measured by centimeter during pre-operative assessment using a ruler
Mouth opening measurement by Centimeter
This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter
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
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
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)

Full Information

First Posted
July 28, 2021
Last Updated
September 5, 2021
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05043779
Brief Title
Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation
Official Title
Is Preoperative Awake Airway Nasoendoscopy A Good Tool To Predict The Expected Difficult Airway In Obese Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult or Failed Intubation, Obesity, Morbid
Keywords
Nasoendoscopy,, Obesity,, Difficult intubation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Awake Airway Nasoendoscopy
Arm Type
Other
Arm Description
only one arm
Intervention Type
Procedure
Intervention Name(s)
Awake Airway Nasoendoscopy
Intervention Description
Preoperative Awake Airway Nasoendoscopy of upper airway
Primary Outcome Measure Information:
Title
Naso-endoscopy views from nose to larynx in obese patients using NOHL score during pre-operative assessment.
Description
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)
Time Frame
During pre-operative assessment.
Secondary Outcome Measure Information:
Title
Measurement of neck circumference in Centimeter
Description
This will be measured by centimeter during pre-operative assessment using a ruler
Time Frame
During pre-operative assessment.
Title
Mouth opening measurement by Centimeter
Description
This will be measured by centimeter between incisors during pre-operative assessment using a ruler and documented by Centimeter
Time Frame
During pre-operative assessment.
Title
Thyro-mental distance measurement by Centimeter
Description
This will be measured by centimeter from thyroid cartilage to patient's chin during pre-operative assessment using a rule
Time Frame
During pre-operative assessment.
Title
Difficult mask ventilation score (1 -3)
Description
Degree of Difficulty in mask ventilation will be graded (1= easy, 2= difficult or 3=impossible) during induction of general anaesthesia
Time Frame
During Induction of anesthesia
Title
Cormak-Lehans grade during induction of anaesthesia
Description
Cormak-Lehans Score will graded during endotracheal intubation and exposure of the larynx. (Grade 1= easy intubation while grade Grade 4= very difficult intubation)
Time Frame
During intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients on the tracheostomy tube Patients who are unable to give consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nabil Shallik, M.D.
Phone
9745543926
Email
nshallik@hamad.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil Shallik, M.D.
Organizational Affiliation
Hamad Medical Corporation - HMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACC, Hamad Medical Corporation
City
Doha
State/Province
Doah
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabil Shallik, M.D.
Phone
55439284
Email
nshallik@outlook.com
First Name & Middle Initial & Last Name & Degree
Mohamed A. Elarref, M.D.
First Name & Middle Initial & Last Name & Degree
Mayed Radi, M.D.
First Name & Middle Initial & Last Name & Degree
Olfa Al Mannai, M.D.
First Name & Middle Initial & Last Name & Degree
Adnan Saad Eddin, MBBcH
First Name & Middle Initial & Last Name & Degree
Yasser Hammad, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share after IRB approval
IPD Sharing Time Frame
After approval IRB directly
IPD Sharing Access Criteria
Through Website
Citations:
PubMed Identifier
1595845
Citation
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.
Results Reference
result
PubMed Identifier
11270007
Citation
Janssens 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 Reference
result
PubMed Identifier
21610502
Citation
Qudaisat 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 Reference
result
PubMed Identifier
10781266
Citation
Langeron 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 Reference
result
PubMed Identifier
18420866
Citation
Tremblay 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 Reference
result
PubMed Identifier
3592174
Citation
Samsoon 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 Reference
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PubMed Identifier
15567809
Citation
Sun 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 Reference
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PubMed Identifier
19194154
Citation
Lundstrom 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.
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PubMed Identifier
22340664
Citation
Heinrich 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.
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PubMed Identifier
15527629
Citation
Collins 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.
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PubMed Identifier
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Citation
Brodsky 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.
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PubMed Identifier
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Citation
Wilson 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.
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Citation
Vicini 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.
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Citation
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Evaluation of Preoperative Nasoendoscopy to Predict Difficult Intubation

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