Intubation; Difficult or FailedNCT04833166
Comparing Full vs. Partial Glottis View Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient
A study testing CMAC D-blade videolaryngoscope with full or partial glottic view in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by University of Malaya at 1 site in Malaysia.
Trial summary
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Airway Complication of Anesthesia
- What is being tested?
- CMAC D-blade videolaryngoscope with full or partial glottic view
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 May 2021to 24 Feb 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with American Society of Anaesthesiologist (ASA) physical status I-III
- Age (≥21-75 years old)
- General anaesthesia requiring tracheal intubation
- Provide written consent to participate in the study
Who cannot join
- Pregnancy
- Body mass index (BMI) ≥ 35
- Condition requires rapid sequence induction
- Need for fibreoptic intubation
- Need for nasal intubation
- Documented difficult airway during previous surgery
Show all 9Show fewer
- Recent (3 months) active ischemic heart disease
- Recent (3 months) cerebrovascular disease
- Acute exacerbation of respiratory disease (eg. Uncontrolled asthma, Chronic Obstructive Pulmonary Disease)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 58200
About this study
Official title: A Randomized Controlled Trial Comparing Full Glottis View vs. Partial Glottis View During Intubation Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations.
D-blade comes with an elliptically tapered blade shape rising at the distal end to provide better glottic visualization in comparison with direct laryngoscopes. Hence, CMAC D-blade is preferred in simulated cervical spine injury where intubator needs to maintain a neutral neck position. However, intubation time may be significantly longer due to difficulty in negotiating the endotracheal tube pass vocal cord and impingement of endotracheal tube to the anterior wall of trachea.
There is a study published Glidescope which is also a hyperangulated videolaryngoscope suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to the full glottic view vs. partial glottic view which is deliberately obtained when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.
Read the detailed description
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide the best laryngeal view for intubation. In cervical spine patients, this alignment is not possible resulting in an increased risk of failed intubations. Difficult intubation and failed tracheal intubation are among the major causes of morbidity and mortality associated with anesthesia.
In recent years, video laryngoscope has played an increasingly important role in the management of patients with unanticipated difficult or failed endotracheal intubation. When compared with a direct laryngoscope, the video laryngoscope achieved a better view of the glottis and a high rate of successful intubation.
On comparing the C-MAC with the conventional Macintosh blade, a conventional C-MAC Macintosh blade 3 and D-blade have a blade angulation of 18° and 40° in the D-blade respectively. In addition, with D-blade is an elliptically tapered blade-shaped rising to distal.
This highly angulated C-MAC D blade provides a better glottic visualization in comparison to the direct laryngoscopes and in simulated cervical spine injury. This resulted in successful intubation in routine induction of anesthesia and rescue intubation in patients with difficult airway with C-MAC D Blade. But in terms of intubation time, study has shown a significantly shorter time with C-MAC D Blade compared with other indirect laryngoscopes. This may be due to a common problem seen in indirect video laryngoscopy whereby a good glottic view does not always allow advancing the tube into the trachea.
A study has been conducted on Glidescope which is also a hyperangulated blade suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. Randomised controlled trial also showed that GlideScope and C-MAC D blade video laryngoscope using manual inline axial stabilization (MIAS) for tracheal intubation in patients with cervical spine injury/pathology were equally efficacious.
The aim of this study is to clinically evaluate the time of tracheal intubation in relation to deliberately obtained full glottic view vs. partial glottic view when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.
- Being tested
- CMAC D-blade videolaryngoscope with full or partial glottic view
- Keywords
- Glottic view, Intubation time, C MAC D- blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAC D-blade videolaryngoscope with full or partial glottic viewDevice
Deliberate achieving full or partial glottic view on C MAC D-blade video laryngoscope and comparing time and ease of intubation with both arms
| Study group | Role | What they receive |
|---|---|---|
| Full glottic view on CMAC- D blade | Experimental | Deliberately obtaining a full glottis view is defined as negotiation and advancement of CMAC D blade tip positioned at the vallecula. Occasionally, external laryngeal pressure may be needed to assist in obtaining a full glottic view. The full glottic view is defined as a percentage of glottic opening (POGO) approximate 100%. Receives: Device: CMAC D-blade videolaryngoscope with full or partial glottic view |
| Partial glottic view on CMAC- D blade | Active comparator | The partial glottis view is defined as a percentage of glottic opening <50%. This is achieved by deliberately position the CMAC D-blade tip proximally away from the vallecular. Receives: Device: CMAC D-blade videolaryngoscope with full or partial glottic view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
This is the time taken from CMAC laryngoscope blade passes patient's lip until the recording of first end tidal CO2 (EtCO2); assessed up to 120 seconds.
Measured: during the intervention
First attempt successful intubation attempt
First intubation attempt success rate between two groups; assessed up to maximum 2 attempts
Measured: during the intervention
Secondary outcomes (3)
Time to obtain glottic view
Time taken for from CMAC laryngoscope blade passes patient's lip until achieving assigned laryngoscopic view; assessed up to 120 seconds
Measured: during the intervention
Hemodynamic changes
Blood pressure, mean arterial pressure and heart rate recorded 1 min, 2.5 min then 5 min post intubation
Measured: immediately after the intervention
Airway trauma
Incidence of oral mucosal trauma, lip laceration, dental laceration; assessed up to discharge from operating theatre.
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start25 May 2021
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheong Chao Chia, University of Malaya
- Investigators
- Siu Min Lim, MMed Master, Study director, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833166
- Sponsor's protocol ID
- MREC: 202093-9041
- Status last verified
- Sep 2022
- First submitted
- 1 Mar 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adnet F, Borron SW, Lapostolle F, Lapandry C. The three axis alignment theory and the "sniffing position": perpetuation of an anatomic myth? Anesthesiology. 1999 Dec;91(6):1964-5. doi: 10.1097/00000542-199912000-00060. No abstract available.
PubMed 10598648Criswell JC, Parr MJ, Nolan JP. Emergency airway management in patients with cervical spine injuries. Anaesthesia. 1994 Oct;49(10):900-3. doi: 10.1111/j.1365-2044.1994.tb04271.x.
PubMed 7802192Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
PubMed 2339799Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Stroumpoulis K, Pagoulatou A, Violari M, Ikonomou I, Kalantzi N, Kastrinaki K, Xanthos T, Michaloliakou C. Videolaryngoscopy in the management of the difficult airway: a comparison with the Macintosh blade. Eur J Anaesthesiol. 2009 Mar;26(3):218-22. doi: 10.1097/EJA.0b013e32831c84d1.
PubMed 19237983Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3.
PubMed 21897263Lewis SR, Butler AR, Parker J, Cook TM, Schofield-Robinson OJ, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation: a Cochrane Systematic Review. Br J Anaesth. 2017 Sep 1;119(3):369-383. doi: 10.1093/bja/aex228.
PubMed 28969318Cavus E, Neumann T, Doerges V, Moeller T, Scharf E, Wagner K, Bein B, Serocki G. First clinical evaluation of the C-MAC D-Blade videolaryngoscope during routine and difficult intubation. Anesth Analg. 2011 Feb;112(2):382-5. doi: 10.1213/ANE.0b013e31820553fb. Epub 2010 Dec 14.
PubMed 21156978Jain D, Dhankar M, Wig J, Jain A. Comparison of the conventional CMAC and the D-blade CMAC with the direct laryngoscopes in simulated cervical spine injury--a manikin study. Braz J Anesthesiol. 2014 Jul-Aug;64(4):269-74. doi: 10.1016/j.bjane.2013.06.005. Epub 2013 Dec 25.
PubMed 24998112Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.
PubMed 23032922van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db.
PubMed 19690253Gu Y, Robert J, Kovacs G, Milne AD, Morris I, Hung O, MacQuarrie K, Mackinnon S, Adam Law J. A deliberately restricted laryngeal view with the GlideScope(R) video laryngoscope is associated with faster and easier tracheal intubation when compared with a full glottic view: a randomized clinical trial. Can J Anaesth. 2016 Aug;63(8):928-37. doi: 10.1007/s12630-016-0654-6. Epub 2016 Apr 18.
PubMed 27090535Cheong CC, Ong SY, Lim SM, Wan A WZ, Mansor M, Chaw SH. Partial vs full glottic view with CMACTM D blade intubation of airway with simulated cervical spine injury: a randomized controlled trial. Expert Rev Med Devices. 2023 Feb;20(2):151-160. doi: 10.1080/17434440.2023.2174850. Epub 2023 Feb 6.
PubMed 36715659
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Full Glottis View vs. Partial Glottis View During Intubation Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient
- ClinicalTrials.gov ID
- NCT04833166
- Acronym / sponsor ID
- MREC: 202093-9041
- Keywords
- Glottic view, Intubation time, C MAC D- blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 6 Apr 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.
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations.
D-blade comes with an elliptically tapered blade shape rising at the distal end to provide better glottic visualization in comparison with direct laryngoscopes. Hence, CMAC D-blade is preferred in simulated cervical spine injury where intubator needs to maintain a neutral neck position. However, intubation time may be significantly longer due to difficulty in negotiating the endotracheal tube pass vocal cord and impingement of endotracheal tube to the anterior wall of trachea.
There is a study published Glidescope which is also a hyperangulated videolaryngoscope suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to the full glottic view vs. partial glottic view which is deliberately obtained when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.
Detailed description
Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide the best laryngeal view for intubation. In cervical spine patients, this alignment is not possible resulting in an increased risk of failed intubations. Difficult intubation and failed tracheal intubation are among the major causes of morbidity and mortality associated with anesthesia.
In recent years, video laryngoscope has played an increasingly important role in the management of patients with unanticipated difficult or failed endotracheal intubation. When compared with a direct laryngoscope, the video laryngoscope achieved a better view of the glottis and a high rate of successful intubation.
On comparing the C-MAC with the conventional Macintosh blade, a conventional C-MAC Macintosh blade 3 and D-blade have a blade angulation of 18° and 40° in the D-blade respectively. In addition, with D-blade is an elliptically tapered blade-shaped rising to distal.
This highly angulated C-MAC D blade provides a better glottic visualization in comparison to the direct laryngoscopes and in simulated cervical spine injury. This resulted in successful intubation in routine induction of anesthesia and rescue intubation in patients with difficult airway with C-MAC D Blade. But in terms of intubation time, study has shown a significantly shorter time with C-MAC D Blade compared with other indirect laryngoscopes. This may be due to a common problem seen in indirect video laryngoscopy whereby a good glottic view does not always allow advancing the tube into the trachea.
A study has been conducted on Glidescope which is also a hyperangulated blade suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. Randomised controlled trial also showed that GlideScope and C-MAC D blade video laryngoscope using manual inline axial stabilization (MIAS) for tracheal intubation in patients with cervical spine injury/pathology were equally efficacious.
The aim of this study is to clinically evaluate the time of tracheal intubation in relation to deliberately obtained full glottic view vs. partial glottic view when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full glottic view on CMAC- D blade | Experimental | Device: CMAC D-blade videolaryngoscope with full or partial glottic viewDeliberately obtaining a full glottis view is defined as negotiation and advancement of CMAC D blade tip positioned at the vallecula. Occasionally, external laryngeal pressure may be needed to assist in obtaining a full glottic view. The full glottic view is defined as a percentage of glottic opening (POGO) approximate 100%. |
| Partial glottic view on CMAC- D blade | Active comparator | Device: CMAC D-blade videolaryngoscope with full or partial glottic viewThe partial glottis view is defined as a percentage of glottic opening <50%. This is achieved by deliberately position the CMAC D-blade tip proximally away from the vallecular. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with American Society of Anaesthesiologist (ASA) physical status I-III
- Age (≥21-75 years old)
- General anaesthesia requiring tracheal intubation
- Provide written consent to participate in the study
Key exclusion criteria (9 listed)
- Pregnancy
- Body mass index (BMI) ≥ 35
- Condition requires rapid sequence induction
- Need for fibreoptic intubation
- Need for nasal intubation
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 |
|---|---|---|
| CMAC D-blade videolaryngoscope with full or partial glottic viewDeliberate achieving full or partial glottic view on C MAC D-blade video laryngoscope and comparing time and ease of intubation with both arms | Device | Full glottic view on CMAC- D blade, Partial glottic view on CMAC- D blade |
Primary outcome
Intubation time
Time frame: during the intervention
This is the time taken from CMAC laryngoscope blade passes patient's lip until the recording of first end tidal CO2 (EtCO2); assessed up to 120 seconds.
First attempt successful intubation attempt
Time frame: during the intervention
First intubation attempt success rate between two groups; assessed up to maximum 2 attempts
3 secondary outcomes
Time to obtain glottic view
Time frame: during the intervention
Hemodynamic changes
Time frame: immediately after the intervention
Airway trauma
Time frame: immediately after the surgery
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 13 Sep 2022.
- Background: PubMed 10598648Adnet F, Borron SW, Lapostolle F, Lapandry C. The three axis alignment theory and the "sniffing position": perpetuation of an anatomic myth? Anesthesiology. 1999 Dec;91(6):1964-5. doi: 10.1097/00000542-199912000-00060. No abstract available.
- Background: PubMed 7802192Criswell JC, Parr MJ, Nolan JP. Emergency airway management in patients with cervical spine injuries. Anaesthesia. 1994 Oct;49(10):900-3. doi: 10.1111/j.1365-2044.1994.tb04271.x.
- Background: PubMed 2339799Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
- Background: PubMed 15271750Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
- Background: PubMed 19237983Stroumpoulis K, Pagoulatou A, Violari M, Ikonomou I, Kalantzi N, Kastrinaki K, Xanthos T, Michaloliakou C. Videolaryngoscopy in the management of the difficult airway: a comparison with the Macintosh blade. Eur J Anaesthesiol. 2009 Mar;26(3):218-22. doi: 10.1097/EJA.0b013e32831c84d1.
- Background: PubMed 21897263Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3.
- Background: PubMed 28969318Lewis SR, Butler AR, Parker J, Cook TM, Schofield-Robinson OJ, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation: a Cochrane Systematic Review. Br J Anaesth. 2017 Sep 1;119(3):369-383. doi: 10.1093/bja/aex228.
- Background: PubMed 21156978Cavus E, Neumann T, Doerges V, Moeller T, Scharf E, Wagner K, Bein B, Serocki G. First clinical evaluation of the C-MAC D-Blade videolaryngoscope during routine and difficult intubation. Anesth Analg. 2011 Feb;112(2):382-5. doi: 10.1213/ANE.0b013e31820553fb. Epub 2010 Dec 14.
- Background: PubMed 24998112Jain D, Dhankar M, Wig J, Jain A. Comparison of the conventional CMAC and the D-blade CMAC with the direct laryngoscopes in simulated cervical spine injury--a manikin study. Braz J Anesthesiol. 2014 Jul-Aug;64(4):269-74. doi: 10.1016/j.bjane.2013.06.005. Epub 2013 Dec 25.
- Background: PubMed 23032922Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.
- Background: PubMed 19690253van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db.
- Background: PubMed 27090535Gu Y, Robert J, Kovacs G, Milne AD, Morris I, Hung O, MacQuarrie K, Mackinnon S, Adam Law J. A deliberately restricted laryngeal view with the GlideScope(R) video laryngoscope is associated with faster and easier tracheal intubation when compared with a full glottic view: a randomized clinical trial. Can J Anaesth. 2016 Aug;63(8):928-37. doi: 10.1007/s12630-016-0654-6. Epub 2016 Apr 18.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
Not yet recruitingObservational study
Effect of High-Flow Nasal Oxygen on Laryngoscopic View
High Flow Nasal Canula, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
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.
Siu Min Lim, MMed Master study director
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMAC D-blade videolaryngoscope with full or partial glottic view in people with Intubation; Difficult or Failed and Airway Complication of Anesthesia, run by University of Malaya at 1 site in Malaysia.
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 9 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 13 Sep 2022. 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 Malaysia. 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?
Intubation time (time frame: during the intervention). The study lists 2 primary outcomes in all. 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 NCT04833166, which also lists 13 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 13 Sep 2022.