Airway MorbidityNCT04991545
Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
A study testing Application of Infrared (Active IRD/ IRRIS) device in people with Airway Morbidity and Covid19, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity, Covid19, Trachea
- What is being tested?
- Application of Infrared (Active IRD/ IRRIS) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteQatar
- Study dates
- 13 Jan 2021to 1 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years
- General anesthesia that needs endotracheal intubation
- All Mallampati score 1-3
- ASA physical status 1-3
Who cannot join
- Refuse or unable to sign the consent.
- Pregnancy
- Emergency cases
- History of or expected difficult intubation
- Maxillofacial abnormality or trauma
- Age below 18 years
Show all 10Show fewer
- Rapid sequence induction
- Skin disorders and skin light sensitivity (SLE, Lupus ….)
- Impaired head and neck mobility
- Scars or skin injuries at the neck
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
ACC&HGH, Hamad Medical Corporation
Doha, Doah, 3050
Nabil Shallik, M.D., 9745543926, nshallik@outlook.com
Elsayyed Elkarta, M.D.
About this study
Official title: Feasibility of the RetrogradeTranscutaneous Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
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.
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Read the 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
- Conditions
- Airway Morbidity, Covid19, Trachea
- Being tested
- Application of Infrared (Active IRD/ IRRIS) device
- Keywords
- Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation
- Medical subject headings
- COVID-19, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Infrared (Active IRD/ IRRIS) deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: control group (intubation without IRD/IRRIS device) | No intervention | 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. |
| Intervention group using Infrared (Active IRD/ IRRIS) device | Experimental | 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 Receives: Device: Application of Infrared (Active IRD/ IRRIS) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During procedure time
Secondary outcomes (7)
Visibility of the glottic entrance
Visibility of the glottic entrance during intubation
Measured: During procedure time
Time to recognize the illuminated laryngeal inlet.
Time to recognize the illuminated laryngeal inlet.
Measured: one year
Correct intubation
Recognize the correct intubation pathway by other confirmatory tests
Measured: one year
Number of intubation attempt.
Number of intubation attempt by the experience staff.
Measured: During procedure time
Types of video laryngoscopy
Types of video laryngoscopy used
Measured: During procedure time
Alternative techniques of intubation.
Alternative techniques of intubation if used after failure of primary equipment
Measured: During procedure time
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)
Measured: During procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start13 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- NCT04991545
- Sponsor's protocol ID
- MRC-05-088
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the data after IRB approval
Publications
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.
PubMed 22315326Sakles 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.
PubMed 23574475Webb 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.
PubMed 8273871Duggan 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.
PubMed 32357995Knapp 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.
PubMed 10195521Nemec D, Austin PN, Silvestro LS. Methods to Improve Success With the GlideScope Video Laryngoscope. AANA J. 2015 Dec;83(6):389-97.
PubMed 26742332Saima 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.
PubMed 26742405Kristensen 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.
PubMed 29063583Wayne 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.
PubMed 20199237
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the RetrogradeTranscutaneous Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
- ClinicalTrials.gov ID
- NCT04991545
- Acronym / sponsor ID
- MRC-05-088
- Conditions
- Airway Morbidity, Covid19, Trachea
- Keywords
- Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 5 Aug 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: control group (intubation without IRD/IRRIS device) | No intervention | –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. |
| Intervention group using Infrared (Active IRD/ IRRIS) device | Experimental | Device: Application of Infrared (Active IRD/ IRRIS) deviceGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years
- General anesthesia that needs endotracheal intubation
- All Mallampati score 1-3
- ASA physical status 1-3
Key exclusion criteria (10 listed)
- Refuse or unable to sign the consent.
- Pregnancy
- Emergency cases
- History of or expected difficult intubation
- Maxillofacial abnormality or trauma
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 |
|---|---|---|
| Application of Infrared (Active IRD/ IRRIS) deviceThe 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: 1. Group A: control group 2. Group B: Intervention group using Infrared | Device | Intervention group using Infrared (Active IRD/ IRRIS) device |
Primary outcome
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
Time frame: During procedure time
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
7 secondary outcomes
Visibility of the glottic entrance
Time frame: During procedure time
Time to recognize the illuminated laryngeal inlet.
Time frame: one year
Correct intubation
Time frame: one year
Number of intubation attempt.
Time frame: During procedure time
Types of video laryngoscopy
Time frame: During procedure time
Alternative techniques of intubation.
Time frame: During procedure time
Safety of Infra Red
Time frame: During procedure time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Results publication: PubMed 22315326Simpson 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 publication: PubMed 23574475Sakles 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 publication: PubMed 8273871Webb 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 publication: PubMed 32357995Duggan 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 publication: PubMed 10195521Knapp 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 publication: PubMed 26742332Nemec D, Austin PN, Silvestro LS. Methods to Improve Success With the GlideScope Video Laryngoscope. AANA J. 2015 Dec;83(6):389-97.
- Results publication: PubMed 26742405Saima 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 publication: PubMed 29063583Kristensen 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 publication: PubMed 20199237Wayne 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.
- Individual participant dataSharing planned: Yes. We will share the data 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 Application of Infrared (Active IRD/ IRRIS) device in people with Airway Morbidity and Covid19, 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 4 inclusion and 10 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 5 Aug 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 (+97444393817, nshallik@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success (time frame: During procedure time). 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 NCT04991545, which also lists 9 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 5 Aug 2021.