Video LaryngoscopeDLTNCT06759038
C-MAC Blade D Video Vs Macintosh Laryngoscope for Double Lumen Tube Insertion
A study testing C-MAC blade D video laryngoscope and Macintosh Laryngoscope in people with Video Laryngoscope and Double Lumen Tube Intubation, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to know which type of laryngoscope is better for Double Lumen Tube (DLT) insertion, in participants undergoing elective thoracic surgeries. The main question aim to answer is Is C-MAC blade D video laryngoscope better than Macintosh laryngoscope for DLT insertion in term of time… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Video Laryngoscope, Double Lumen Tube Intubation, Elective Thoracic Surgery
- What is being tested?
- C-MAC blade D video laryngoscope and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Dec 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mallampati 1 and 2.
- ASA 1 and 2.
- Patients who will be prepared for elective thoracic surgeries under general anesthesia.
Who cannot join
- Pregnant Patients.
- Patients with anticipated difficult airway.
- Patients with limited neck extension.
- Thyromental distance less than 6.5cm.
- BMI greater than 35. (Weight in kilogram (kg) divided by height in meters squared)
- Patients at a risk of aspiration.
- Failure to intubate the patient after 3 attempts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, pain Fellow contact
Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS,MCPS, FCPS contact
Pakistan1 site, 1 recruiting
- Recruiting
Shaheed Mohtarma Benazir Bhutto Institute of Trauma
Karachi, Sindh
Sidra Tahir, MBBS, FCPS II trainee
Sidra Javed Assistant Professor, MBBS, FCPS, Pain Fellow
About this study
Official title: Comparison Between C-MAC Blade D Video Laryngoscope and Macintosh Laryngoscope for Double Lumen Tube Insertion in Patients Undergoing Elective Thoracic Surgeries
The goal of this clinical trial is to know which type of laryngoscope is better for Double Lumen Tube (DLT) insertion, in participants undergoing elective thoracic surgeries.
The main question aim to answer is Is C-MAC blade D video laryngoscope better than Macintosh laryngoscope for DLT insertion in term of time taking for intubation and hemodynamic changes to laryngoscopy? Researchers are comparing two groups of participants
- Participants in Group A are receiving intubation from C-MAC blade D video laryngoscope.
- Participants in Group B are receiving intubations from Macintosh laryngoscope.
Read the detailed description
Double Lumen Tube (DLT) is a common airway management device, used to implement lung isolation technique during thoracic surgeries. Intubation of DLT is challenging because it is much larger in diameter and rotational insertion technique is associated with significant risk of prolong intubation, intubation failure, greater hemodynamic changes and airway trauma.
Objective of this study is to compare the outcome C-MAC blade D video laryngoscope and Macintosh laryngoscope for DLT insertion, in term of time taking for DLT intubation and hemodynamic changes to laryngoscopy.
This study is conducting at Department of Anesthesiology at SMBBIT, Pakistan. Data is collecting after taking approval from Ethical Review Committee and written informed consent from participants.
Participants are enrolling by primary investigator, day before surgery. All participants are undergoing simple randomization by lottery method.
During induction of aesthesia, time for intubation is noting from introduction of the laryngoscope blade till three complete capnograph cycles.
Participants have also been assessed for hemodynamic parameters {Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP)} to intubation at 0 (Baseline), 1st Minute , 3rd Minute and 5th Minute after intubation.
After Completing data collection, Data analysis will be done by using SPSS version 26.
- Being tested
- C-MAC blade D video laryngoscope, Macintosh Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC blade D video laryngoscopeDevice
C-MAC blade D Video Laryngoscope is used for difficult intubation and for better glottic view
Macintosh LaryngoscopeDevice
Macintosh Laryngoscope is conventional laryngoscope used generally for intubations
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscope Group | Experimental | Those participants who will randomly assigned for intubations with C-MAC Blade D Video laryngoscope are placed in Group A Receives: Device: C-MAC blade D video laryngoscope |
| Macintosh laryngoscope Group | Active comparator | Those participants who will randomly assigned for intubations with Macintosh Laryngoscope are placed in Group B Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for intubation
1st outcome is time for intubation time for intubation will be noted during intubation of Double Lumen Tube. Time start from introduction of laryngoscope blade till three complete capnograph cycles.
Measured: During induction of anesthesia, It will take 10 to 15 minutes
Heart Rate changes to laryngoscopy
Heart Rate of a patient will be noted before induction of Anaesthesia as baseline heart rate and will be labelled as 0. Then at 1 minute, at 3 minutes and at 5 minutes after intubation, and labelled as 1 ,3 \& 5.
Measured: From enrollment till completion it will take approximately 24 hours
Blood pressure changes to laryngoscopy
Changes of blood pressure to laryngoscopy as Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DPB) and Mean Arterial Pressure (MAP) will be noted before induction of anesthesia as baseline and labelled as 0. Then at 1 minute, 3 minutes and 5 minutes after intubation and labelled as 1, 3 and 5.
Measured: Time from enrolment to completion will be 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start3 Dec 2024
- Primary completion28 Feb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Video LaryngoscopeStudies 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
- There are two groups of participants Group A and Group B. Allocation of participants in each group is done by basic randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of Trauma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidra Tahir, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759038
- Sponsor's protocol ID
- ERC-000146/SMBBIT/2024
- Acronym
- DLT
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity Informed Consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
Publications
Smereka J, Ladny JR, Naylor A, Ruetzler K, Szarpak L. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial. Am J Emerg Med. 2017 Aug;35(8):1142-1146. doi: 10.1016/j.ajem.2017.03.030. Epub 2017 Mar 16.
PubMed 28341185Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.
PubMed 32857788Liu HH, Dong F, Liu JY, Wei JQ, Huang YK, Wang Y, Zhou T, Ma WH. The use of ETView endotracheal tube for surveillance after tube positioning in patients undergoing lobectomy, randomized trial. Medicine (Baltimore). 2018 Dec;97(49):e13170. doi: 10.1097/MD.0000000000013170.
PubMed 30544376Tao D, Zhang G, Zheng X, Wang X, Gao G, Yang Z, Lin Y, Lu L. Feasibility study of intubation in lateral position using Viva-sight double-lumen tube combined with video laryngoscope in patients undergoing pulmonary lobectomy. Asian J Surg. 2024 Jan;47(1):373-379. doi: 10.1016/j.asjsur.2023.08.199. Epub 2023 Sep 9.
PubMed 37696694
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between C-MAC Blade D Video Laryngoscope and Macintosh Laryngoscope for Double Lumen Tube Insertion in Patients Undergoing Elective Thoracic Surgeries
- ClinicalTrials.gov ID
- NCT06759038
- Acronym / sponsor ID
- DLT / ERC-000146/SMBBIT/2024
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shaheed Mohtarma Benazir Bhutto Institue of TraumaUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Jan 2025 (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.
The goal of this clinical trial is to know which type of laryngoscope is better for Double Lumen Tube (DLT) insertion, in participants undergoing elective thoracic surgeries.
The main question aim to answer is Is C-MAC blade D video laryngoscope better than Macintosh laryngoscope for DLT insertion in term of time taking for intubation and hemodynamic changes to laryngoscopy? Researchers are comparing two groups of participants
- Participants in Group A are receiving intubation from C-MAC blade D video laryngoscope.
- Participants in Group B are receiving intubations from Macintosh laryngoscope.
Detailed description
Double Lumen Tube (DLT) is a common airway management device, used to implement lung isolation technique during thoracic surgeries. Intubation of DLT is challenging because it is much larger in diameter and rotational insertion technique is associated with significant risk of prolong intubation, intubation failure, greater hemodynamic changes and airway trauma.
Objective of this study is to compare the outcome C-MAC blade D video laryngoscope and Macintosh laryngoscope for DLT insertion, in term of time taking for DLT intubation and hemodynamic changes to laryngoscopy.
This study is conducting at Department of Anesthesiology at SMBBIT, Pakistan. Data is collecting after taking approval from Ethical Review Committee and written informed consent from participants.
Participants are enrolling by primary investigator, day before surgery. All participants are undergoing simple randomization by lottery method.
During induction of aesthesia, time for intubation is noting from introduction of the laryngoscope blade till three complete capnograph cycles.
Participants have also been assessed for hemodynamic parameters {Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP)} to intubation at 0 (Baseline), 1st Minute , 3rd Minute and 5th Minute after intubation.
After Completing data collection, Data analysis will be done by using SPSS version 26.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two groups of participants Group A and Group B. Allocation of participants in each group is done by basic randomization.
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscope Group | Experimental | Device: C-MAC blade D video laryngoscopeThose participants who will randomly assigned for intubations with C-MAC Blade D Video laryngoscope are placed in Group A |
| Macintosh laryngoscope Group | Active comparator | Device: Macintosh LaryngoscopeThose participants who will randomly assigned for intubations with Macintosh Laryngoscope are placed in Group B |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mallampati 1 and 2.
- ASA 1 and 2.
- Patients who will be prepared for elective thoracic surgeries under general anesthesia.
Key exclusion criteria (7 listed)
- Pregnant Patients.
- Patients with anticipated difficult airway.
- Patients with limited neck extension.
- Thyromental distance less than 6.5cm.
- BMI greater than 35. (Weight in kilogram (kg) divided by height in meters squared)
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 |
|---|---|---|
| C-MAC blade D video laryngoscopeC-MAC blade D Video Laryngoscope is used for difficult intubation and for better glottic view | Device | Video laryngoscope Group |
| Macintosh LaryngoscopeMacintosh Laryngoscope is conventional laryngoscope used generally for intubations | Device | Macintosh laryngoscope Group |
Primary outcome
Time for intubation
Time frame: During induction of anesthesia, It will take 10 to 15 minutes
1st outcome is time for intubation time for intubation will be noted during intubation of Double Lumen Tube. Time start from introduction of laryngoscope blade till three complete capnograph cycles.
Heart Rate changes to laryngoscopy
Time frame: From enrollment till completion it will take approximately 24 hours
Heart Rate of a patient will be noted before induction of Anaesthesia as baseline heart rate and will be labelled as 0. Then at 1 minute, at 3 minutes and at 5 minutes after intubation, and labelled as 1 ,3 \& 5.
Blood pressure changes to laryngoscopy
Time frame: Time from enrolment to completion will be 24 hours
Changes of blood pressure to laryngoscopy as Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DPB) and Mean Arterial Pressure (MAP) will be noted before induction of anesthesia as baseline and labelled as 0. Then at 1 minute, 3 minutes and 5 minutes after intubation and labelled as 1, 3 and 5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 28341185Smereka J, Ladny JR, Naylor A, Ruetzler K, Szarpak L. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial. Am J Emerg Med. 2017 Aug;35(8):1142-1146. doi: 10.1016/j.ajem.2017.03.030. Epub 2017 Mar 16.
- Background: PubMed 32857788Kim YS, Song J, Lim BG, Lee IO, Won YJ. Different classes of videoscopes and direct laryngoscopes for double-lumen tube intubation in thoracic surgery: A systematic review and network meta-analysis. PLoS One. 2020 Aug 28;15(8):e0238060. doi: 10.1371/journal.pone.0238060. eCollection 2020.
- Background: PubMed 30544376Liu HH, Dong F, Liu JY, Wei JQ, Huang YK, Wang Y, Zhou T, Ma WH. The use of ETView endotracheal tube for surveillance after tube positioning in patients undergoing lobectomy, randomized trial. Medicine (Baltimore). 2018 Dec;97(49):e13170. doi: 10.1097/MD.0000000000013170.
- Background: PubMed 37696694Tao D, Zhang G, Zheng X, Wang X, Gao G, Yang Z, Lin Y, Lu L. Feasibility study of intubation in lateral position using Viva-sight double-lumen tube combined with video laryngoscope in patients undergoing pulmonary lobectomy. Asian J Surg. 2024 Jan;47(1):373-379. doi: 10.1016/j.asjsur.2023.08.199. Epub 2023 Sep 9.
- Individual participant dataSharing planned: No. Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity Informed Consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.
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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.
Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, pain Fellow contact
Dr Mirza Shahzad Baig Consultant Anaesthetist, MBBS,MCPS, FCPS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC blade D video laryngoscope and Macintosh Laryngoscope in people with Video Laryngoscope and Double Lumen Tube Intubation, run by Shaheed Mohtarma Benazir Bhutto Institue of Trauma at 1 site in Pakistan.
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 7 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Sidra Javed Consultant Anaesthetist, MBBS, FCPS, pain Fellow (+93333 2474831, sidra_dow@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for intubation (time frame: During induction of anesthesia, It will take 10 to 15 minutes). The study lists 3 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 NCT06759038, which also lists 4 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 6 Jan 2025.