Paediatric AirwayNCT04145089
Comparison of Time Taken for Intubation and Cormack Lehane View Between C-Mac With Glidescope Video Laryngoscopy in Paediatric Patients
A study testing Glidescope video laryngoscopy/ C-MAC video laryngoscopy in people with Paediatric Airway, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric Airway
- What is being tested?
- Glidescope video laryngoscopy/ C-MAC video laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2019to 1 Jan 2020
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Paediatric patients 3-12 years old undergoing elective surgery
- American Society of Anesthesiology (ASA) 1-2
- No difficult airway features/history of difficult intubation
- Not obese
Who cannot join
- Any difficult intubation features/history of difficult intubation
- Obese child
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, 56000
About this study
Official title: Comparative Study of Time Taken for Intubation and Cormack Lehane View Between C-Mac Video Laryngoscopy With Glidescope Video Laryngoscopy in Paediatric Patients Undergoing Elective Surgery
This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old.
Read the detailed description
This study aims to determine whether are both devices comparable to each other in terms of intubation time and Cormack Lehane view in paediatric patients with normal airway undergoing elective surgery.
- Conditions
- Paediatric Airway
- Being tested
- Glidescope video laryngoscopy/ C-MAC video laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glidescope video laryngoscopy/ C-MAC video laryngoscopyDevice
usage of said devices according to manual
| Study group | Role | What they receive |
|---|---|---|
| C-Mac intubation | Active comparator | Intubation with C-MAC video laryngoscopy Receives: Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy |
| Glidescope intubation | Active comparator | Intubation with Glidescope video laryngoscopy Receives: Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time taken from insertion of specified laryngoscope blade to lip until presence of capnography tracing
Measured: 5 minutes
Secondary outcomes (1)
Cormack Lehane view
grade from 1-4 by operator's assesment
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Paediatric AirwayStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GlideScope intubation Vs Cmac intubation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syarifah Noor Nazihah Sayed Masri, MD, Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145089
- Sponsor's protocol ID
- FF-2019-004
- Status last verified
- Sep 2019
- First submitted
- 28 Oct 2019
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.
PubMed 19128325Armstrong J, John J, Karsli C. A comparison between the GlideScope Video Laryngoscope and direct laryngoscope in paediatric patients with difficult airways - a pilot study. Anaesthesia. 2010 Apr;65(4):353-7. doi: 10.1111/j.1365-2044.2010.06294.x.
PubMed 20402873Mosier J, Chiu S, Patanwala AE, Sakles JC. A comparison of the GlideScope video laryngoscope to the C-MAC video laryngoscope for intubation in the emergency department. Ann Emerg Med. 2013 Apr;61(4):414-420.e1. doi: 10.1016/j.annemergmed.2012.11.001. Epub 2013 Jan 30.
PubMed 23374414Hurford DM, White MC. A comparison of the Glidescope and Karl Storz DCI videolaryngoscopes in a paediatric manikin. Anaesthesia. 2010 Aug;65(8):781-4. doi: 10.1111/j.1365-2044.2010.06390.x. Epub 2010 Jun 2.
PubMed 20528838Kim JT, Na HS, Bae JY, Kim DW, Kim HS, Kim CS, Kim SD. GlideScope video laryngoscope: a randomized clinical trial in 203 paediatric patients. Br J Anaesth. 2008 Oct;101(4):531-4. doi: 10.1093/bja/aen234. Epub 2008 Aug 8.
PubMed 18689807
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Time Taken for Intubation and Cormack Lehane View Between C-Mac Video Laryngoscopy With Glidescope Video Laryngoscopy in Paediatric Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT04145089
- Acronym / sponsor ID
- FF-2019-004
- Conditions
- Paediatric Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 30 Oct 2019 (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.
This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old.
Detailed description
This study aims to determine whether are both devices comparable to each other in terms of intubation time and Cormack Lehane view in paediatric patients with normal airway undergoing elective surgery.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- GlideScope intubation Vs Cmac intubation
| Arm | Type | Receives |
|---|---|---|
| C-Mac intubation | Active comparator | Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopyIntubation with C-MAC video laryngoscopy |
| Glidescope intubation | Active comparator | Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopyIntubation with Glidescope video laryngoscopy |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Paediatric patients 3-12 years old undergoing elective surgery
- American Society of Anesthesiology (ASA) 1-2
- No difficult airway features/history of difficult intubation
- Not obese
Key exclusion criteria (2 listed)
- Any difficult intubation features/history of difficult intubation
- Obese child
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 |
|---|---|---|
| Glidescope video laryngoscopy/ C-MAC video laryngoscopyusage of said devices according to manual | Device | C-Mac intubation, Glidescope intubation |
Primary outcome
Intubation time
Time frame: 5 minutes
Time taken from insertion of specified laryngoscope blade to lip until presence of capnography tracing
1 secondary outcome
Cormack Lehane view
Time frame: 5 minutes
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 8 Jul 2020.
- Background: PubMed 19128325Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.
- Background: PubMed 20402873Armstrong J, John J, Karsli C. A comparison between the GlideScope Video Laryngoscope and direct laryngoscope in paediatric patients with difficult airways - a pilot study. Anaesthesia. 2010 Apr;65(4):353-7. doi: 10.1111/j.1365-2044.2010.06294.x.
- Background: PubMed 23374414Mosier J, Chiu S, Patanwala AE, Sakles JC. A comparison of the GlideScope video laryngoscope to the C-MAC video laryngoscope for intubation in the emergency department. Ann Emerg Med. 2013 Apr;61(4):414-420.e1. doi: 10.1016/j.annemergmed.2012.11.001. Epub 2013 Jan 30.
- Background: PubMed 20528838Hurford DM, White MC. A comparison of the Glidescope and Karl Storz DCI videolaryngoscopes in a paediatric manikin. Anaesthesia. 2010 Aug;65(8):781-4. doi: 10.1111/j.1365-2044.2010.06390.x. Epub 2010 Jun 2.
- Background: PubMed 18689807Kim JT, Na HS, Bae JY, Kim DW, Kim HS, Kim CS, Kim SD. GlideScope video laryngoscope: a randomized clinical trial in 203 paediatric patients. Br J Anaesth. 2008 Oct;101(4):531-4. doi: 10.1093/bja/aen234. Epub 2008 Aug 8.
- Individual participant dataSharing planned: No
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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.
Syarifah Noor Nazihah Sayed Masri, MD principal investigator
Universiti Kebangsaan Malaysia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glidescope video laryngoscopy/ C-MAC video laryngoscopy in people with Paediatric Airway, run by Universiti Kebangsaan Malaysia Medical Centre 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 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: finished, as of the sponsor's last update on 8 Jul 2020. 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: 5 minutes). 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 NCT04145089, which also lists 5 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 8 Jul 2020.