search
Back to results

Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation

Primary Purpose

Airway Morbidity, Covid19, Trachea

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Application of Infrared (Active IRD/ IRRIS) device
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Morbidity focused on measuring Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age above 18 years
  • General anesthesia that needs endotracheal intubation
  • All Mallampati score 1-3
  • ASA physical status 1-3

Exclusion Criteria:

  • Refuse or unable to sign the consent.
  • Pregnancy
  • Emergency cases
  • History of or expected difficult intubation
  • Maxillofacial abnormality or trauma
  • Age below 18 years
  • Rapid sequence induction
  • Skin disorders and skin light sensitivity (SLE, Lupus ….)
  • Impaired head and neck mobility
  • Scars or skin injuries at the neck

Sites / Locations

  • ACC&HGH, Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A: control group (intubation without IRD/IRRIS device)

Intervention group using Infrared (Active IRD/ IRRIS) device

Arm Description

Group A = control group (intubation without IRD/IRRIS device) (15 subjects) The first operator experienced with video-laryngoscopy intubation will do the endotracheal intubation after induction of anesthesia.

Group B = intervention group using Infrared active IRD/IRRIS device (15 subjects) Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients. After confirming lack of discomfort during application of the IRRIS/IRD device, anesthesia will be induced

Outcomes

Primary Outcome Measures

infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
The primary endpoint will be the feasibility of infrared/near-red light on the performance of video-laryngoscopy tracheal intubation and its impact on first pass success

Secondary Outcome Measures

Visibility of the glottic entrance
Visibility of the glottic entrance during intubation
Time to recognize the illuminated laryngeal inlet.
Time to recognize the illuminated laryngeal inlet.
Correct intubation
Recognize the correct intubation pathway by other confirmatory tests
Number of intubation attempt.
Number of intubation attempt by the experience staff.
Types of video laryngoscopy
Types of video laryngoscopy used
Alternative techniques of intubation.
Alternative techniques of intubation if used after failure of primary equipment
Safety of Infra Red
Safety: Presence and severity of skin lesion that might be associated at device application site. (Discomfort, pressure sign, irritation, redness, burn)

Full Information

First Posted
July 28, 2021
Last Updated
July 28, 2021
Sponsor
Hamad Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04991545
Brief Title
Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
Official Title
Feasibility of the RetrogradeTranscutaneous Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 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
Yes

5. Study Description

Brief Summary
Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation. x
Detailed Description
Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation. The proposal of this study is to assess the feasibility and the impact of infrared/near-infrared (IRD) light on the performance of video-laryngoscopy and reduction of the time needed for endotracheal intubation and increase the credibility of the device. Data-collection will be started after induction of the anesthesia and ended at the confirmation of endotracheal tube position

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Morbidity, Covid19, Trachea
Keywords
Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: control group (intubation without IRD/IRRIS device)
Arm Type
No Intervention
Arm Description
Group A = control group (intubation without IRD/IRRIS device) (15 subjects) The first operator experienced with video-laryngoscopy intubation will do the endotracheal intubation after induction of anesthesia.
Arm Title
Intervention group using Infrared (Active IRD/ IRRIS) device
Arm Type
Experimental
Arm Description
Group B = intervention group using Infrared active IRD/IRRIS device (15 subjects) Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients. After confirming lack of discomfort during application of the IRRIS/IRD device, anesthesia will be induced
Intervention Type
Device
Intervention Name(s)
Application of Infrared (Active IRD/ IRRIS) device
Intervention Description
The first operator experienced with video-laryngoscopy intubation will do Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients After confirming lack of discomfort during application of the IRRIS/IRD device, After complete relaxation, Laryngoscopy will be performed by the first operator using video laryngoscope (Glidescope Verathon Medical, BC, Canada or C-Mac Storz, Germany) to insert the tracheal tube. The endotracheal tube will be armed with a malleable stylet and to be molded to a curved 'hockey stick or the same curve of the laryngoscopic blade's shape. We will divide the patient according to device into two groups: Group A: control group Group B: Intervention group using Infrared
Primary Outcome Measure Information:
Title
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
Description
The primary endpoint will be the feasibility of infrared/near-red light on the performance of video-laryngoscopy tracheal intubation and its impact on first pass success
Time Frame
During procedure time
Secondary Outcome Measure Information:
Title
Visibility of the glottic entrance
Description
Visibility of the glottic entrance during intubation
Time Frame
During procedure time
Title
Time to recognize the illuminated laryngeal inlet.
Description
Time to recognize the illuminated laryngeal inlet.
Time Frame
one year
Title
Correct intubation
Description
Recognize the correct intubation pathway by other confirmatory tests
Time Frame
one year
Title
Number of intubation attempt.
Description
Number of intubation attempt by the experience staff.
Time Frame
During procedure time
Title
Types of video laryngoscopy
Description
Types of video laryngoscopy used
Time Frame
During procedure time
Title
Alternative techniques of intubation.
Description
Alternative techniques of intubation if used after failure of primary equipment
Time Frame
During procedure time
Title
Safety of Infra Red
Description
Safety: Presence and severity of skin lesion that might be associated at device application site. (Discomfort, pressure sign, irritation, redness, burn)
Time Frame
During procedure time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age above 18 years General anesthesia that needs endotracheal intubation All Mallampati score 1-3 ASA physical status 1-3 Exclusion Criteria: Refuse or unable to sign the consent. Pregnancy Emergency cases History of or expected difficult intubation Maxillofacial abnormality or trauma Age below 18 years Rapid sequence induction Skin disorders and skin light sensitivity (SLE, Lupus ….) Impaired head and neck mobility Scars or skin injuries at the neck
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nabil Shallik
Phone
+97444393817
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&HGH, 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
9745543926
Email
nshallik@outlook.com
First Name & Middle Initial & Last Name & Degree
Elsayyed Elkarta, M.D.
First Name & Middle Initial & Last Name & Degree
Odai Khammash, 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 the data after IRB approval
IPD Sharing Time Frame
After IRB approval directly
IPD Sharing Access Criteria
Website
Citations:
PubMed Identifier
22315326
Citation
Simpson GD, Ross MJ, McKeown DW, Ray DC. Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth. 2012 May;108(5):792-9. doi: 10.1093/bja/aer504. Epub 2012 Feb 6.
Results Reference
result
PubMed Identifier
23574475
Citation
Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
Results Reference
result
PubMed Identifier
8273871
Citation
Webb RK, Currie M, Morgan CA, Williamson JA, Mackay P, Russell WJ, Runciman WB. The Australian Incident Monitoring Study: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):520-8. doi: 10.1177/0310057X9302100507.
Results Reference
result
PubMed Identifier
32357995
Citation
Duggan LV, Mastoras G, Bryson GL. Tracheal intubation in patients with COVID-19. CMAJ. 2020 Jun 1;192(22):E607. doi: 10.1503/cmaj.200650. Epub 2020 May 1. No abstract available.
Results Reference
result
PubMed Identifier
10195521
Citation
Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016.
Results Reference
result
PubMed Identifier
26742332
Citation
Nemec D, Austin PN, Silvestro LS. Methods to Improve Success With the GlideScope Video Laryngoscope. AANA J. 2015 Dec;83(6):389-97.
Results Reference
result
PubMed Identifier
26742405
Citation
Saima S, Asai T, Kimura R, Terada S, Arai T, Okuda Y. [Combined Use of a Videolaryngoscope and a Transilluminating Device for Intubation with Two Difficult Airways]. Masui. 2015 Oct;64(10):1045-7. Japanese.
Results Reference
result
PubMed Identifier
29063583
Citation
Kristensen MS, Fried E, Biro P. Infrared Red Intubation System (IRRIS) guided flexile videoscope assisted difficult airway management. Acta Anaesthesiol Scand. 2018 Jan;62(1):19-25. doi: 10.1111/aas.13016. Epub 2017 Oct 24.
Results Reference
result
PubMed Identifier
20199237
Citation
Wayne MA, McDonnell M. Comparison of traditional versus video laryngoscopy in out-of-hospital tracheal intubation. Prehosp Emerg Care. 2010 Apr-Jun;14(2):278-82. doi: 10.3109/10903120903537189.
Results Reference
result

Learn more about this trial

Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation

We'll reach out to this number within 24 hrs