Cervical Spine InstabilityNCT05561231
Comparing Ease of Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery
A study testing Intubation with C blade and Intubation with D blade in people with Cervical Spine Instability, run by King Edward Memorial Hospital, Mumbai at 1 site in India.
Trial summary
This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spine Instability
- What is being tested?
- Intubation with C blade and Intubation with D blade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2018to 1 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA (American Society of Anaesthesiology) grade one and two,
- aged 18 years and older,
- Patients with mouth opening more than two and a half fingers (inter-incisor distance >3cm)
Who cannot join
- Patients who were unwilling to be a part of the study,
- patients with any oral pathology, hiatus hernia, pregnant women,
- patients with severe systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single Blinded Randomised Controlled Trial to Compare Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery
This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.
Read the detailed description
Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.
Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.
- Conditions
- Cervical Spine Instability
- Being tested
- Intubation with C blade, Intubation with D blade
- Keywords
- Manual in-line stabilisation, C blade, D blade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with C bladeProcedure or surgery
Intubation with C blade of CMAC videolaryngoscope
Intubation with D bladeProcedure or surgery
Intubation with D blade of CMAC videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Group of patients intubated with C blade of CMAC videolaryngoscopes Receives: Procedure: Intubation with C blade |
| Group D | Active comparator | Group of patients intubated with D blade of CMAC videolaryngoscope Receives: Procedure: Intubation with D blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for successful intubation
Comparing the time taken for successful intubation using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
Measured: During procedure
Secondary outcomes (2)
Time taken to obtain the best Cormack-Lehane grade
Comparing the time taken to obtain the best Cormack-Lehane grade using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
Measured: During procedure
Number of attempts, external manouvres, complications
Comparing the number of attempts for successful endotracheal intubation, external manoeuvres or adjuncts required, complications caused using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine InstabilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single blinded randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Memorial Hospital, Mumbai
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sandhya Narayanan P, King Edward Memorial Hospital, Mumbai
- Investigators
- Sandhya N Narayanan P, MD, Principal investigator, Seth GSMC and KEMH Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561231
- Sponsor's protocol ID
- EC/182/2018
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hazarika H, Saxena A, Meshram P, Kumar Bhargava A. A randomized controlled trial comparing C Mac D Blade and Macintosh laryngoscope for nasotracheal intubation in patients undergoing surgeries for head and neck cancer. Saudi J Anaesth. 2018 Jan-Mar;12(1):35-41. doi: 10.4103/sja.SJA_239_17.
PubMed 29416454Sinha R, Ray BR, Sharma A, Pandey RK, Punj J, Darlong V, Trikha A. Comparison of the C-MAC video laryngoscope size 2 Macintosh blade with size 2 C-MAC D-Blade for laryngoscopy and endotracheal intubation in children with simulated cervical spine injury: A prospective randomized crossover study. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):509-514. doi: 10.4103/joacp.JOACP_106_18.
PubMed 31920236
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Blinded Randomised Controlled Trial to Compare Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT05561231
- Acronym / sponsor ID
- EC/182/2018
- Conditions
- Cervical Spine Instability
- Keywords
- Manual in-line stabilisation, C blade, D blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- King Edward Memorial Hospital, MumbaiOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 30 Sep 2022 (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 was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.
Detailed description
Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.
Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective single blinded randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Procedure: Intubation with C bladeGroup of patients intubated with C blade of CMAC videolaryngoscopes |
| Group D | Active comparator | Procedure: Intubation with D bladeGroup of patients intubated with D blade of CMAC videolaryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA (American Society of Anaesthesiology) grade one and two,
- aged 18 years and older,
- Patients with mouth opening more than two and a half fingers (inter-incisor distance >3cm)
Key exclusion criteria (3 listed)
- Patients who were unwilling to be a part of the study,
- patients with any oral pathology, hiatus hernia, pregnant women,
- patients with severe systemic diseases
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 |
|---|---|---|
| Intubation with C bladeIntubation with C blade of CMAC videolaryngoscope | Procedure or surgery | Group C |
| Intubation with D bladeIntubation with D blade of CMAC videolaryngoscope | Procedure or surgery | Group D |
Primary outcome
Time taken for successful intubation
Time frame: During procedure
Comparing the time taken for successful intubation using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
2 secondary outcomes
Time taken to obtain the best Cormack-Lehane grade
Time frame: During procedure
Number of attempts, external manouvres, complications
Time frame: During procedure
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 30 Sep 2022.
- Background: PubMed 29416454Hazarika H, Saxena A, Meshram P, Kumar Bhargava A. A randomized controlled trial comparing C Mac D Blade and Macintosh laryngoscope for nasotracheal intubation in patients undergoing surgeries for head and neck cancer. Saudi J Anaesth. 2018 Jan-Mar;12(1):35-41. doi: 10.4103/sja.SJA_239_17.
- Background: PubMed 31920236Sinha R, Ray BR, Sharma A, Pandey RK, Punj J, Darlong V, Trikha A. Comparison of the C-MAC video laryngoscope size 2 Macintosh blade with size 2 C-MAC D-Blade for laryngoscopy and endotracheal intubation in children with simulated cervical spine injury: A prospective randomized crossover study. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):509-514. doi: 10.4103/joacp.JOACP_106_18.
- Individual participant dataSharing planned: No
Related trials for Cervical Spine Instability
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Enrolling by invitationObservational study
Cervical Interbody Implant Study
Degenerative Disc Disease, Cervical Spinal Instability
Enrolling by invitationObservational study
Posterior Cervical Fixation Study
Degenerative Disc Disease, Craniocervical Injuries
Active, not recruitingObservational study
Cervical Spine Abnormalities in Down Syndrome
Down Syndrome, Cervical Spine Instability in Down Syndrome
Enrolling by invitationObservational study
Treatment of One and/or Two Level Cervical Degenerative Disc Disease
Cervical Radiculopathy
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.
Sandhya N Narayanan P, MD principal investigator
Seth GSMC and KEMH Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation with C blade and Intubation with D blade in people with Cervical Spine Instability, run by King Edward Memorial Hospital, Mumbai at 1 site in India.
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 3 inclusion and 3 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 30 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 India. 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?
Time taken for successful intubation (time frame: During procedure). 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 NCT05561231, which also lists 2 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 30 Sep 2022.