To Compare Success Rate of Video Laryngoscopy vs Direct LaryngoscopyNCT06327867
Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department
A study testing Oro Tracheal Intubation by DL and Oro Tracheal Intubation by VL in people with To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy, run by Patan Academy of Health Sciences.
Trial summary
This is an open-label, single center, prospective, randomized, comparative, intervention study. The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy
- What is being tested?
- Oro Tracheal Intubation by DL and Oro Tracheal Intubation by VL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2025
- 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
- Age 18 years
- Patient requiring orotracheal intubation
- Those who give written informed consent
Who cannot join
- Pregnancy
- Intubations done by medical officers
Trial locations and contacts
No sites are listed yet.
About this study
This is an open-label, single center, prospective, randomized, comparative, intervention study.
The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:
- To assess the adverse events during video laryngoscopy
- To assess the adverse events during direct Laryngoscopy
- To compare the first pass success rate of DL vs VL according to demographic profile (age and sex)
Read the detailed description
All consecutive patients presenting in Emergency medicine room requiring intubation, will be recruited in this study after taking informed written consent from the patients' family, excluding those falling in exclusion criteria. Direct laryngoscopy will be done by Mackintosh Laryngoscope with blade no 3 or 4. Video Laryngoscopy will be done by Mcgrath Mac Video Laryngoscope in respective groups. Intubations will be done by ER physicians and Emergency fellows of Emergency department. The total number of required sample size will be calculated and the obtained number will be divided in a group of 21 with block of 6 each. After randomizing the group and the block from a computerized software, a total of 21 envelope will be prepared in a consecutive manner and the patient will be intubated as per the pre decided blocks. All the patients in emergency who require intubation and falling into the inclusion criteria will be assessed. Informed written consent will be taken from the patient's family explaining that they will be a part of study and either of the laryngoscopy method will be used in them. Informed consent will be taken by one of the investigators, (ER physicians and emergency medicine fellow) who will be performing intubations in them.Inclusion criteria-
- Age 18 years
- Patient requiring orotracheal intubation
- Those who give written informed consent
Exclusion criteria-
- Pregnancy
- Intubations done by medical officers
Randomization-
- The consecutive patients will be assigned numbers serially from one.
- Block randomization of the patients in two arms will be done by using computerized software.
A total of 63 patients in each arm with total 126 patients will be included in the study. Blocks of 6 will be taken with total 21 groups. With using the software, random group will be selected and intubations will be done accordingly.
Demographic and clinical profile of patients in both arms will be recorded. Two treatment arms-
- Arm A- Orotracheal intubation done by Direct Laryngoscopy
- Arm B- Orotracheal intubation done by Video Laryngoscopy
Outcomes Primary- First pass success of direct laryngoscopy in oro tracheal intubation First pass success of video laryngoscopy in oro tracheal intubation
Secondary- Complications rates between two methods. Use of alternative methods for ventilation or oxygenation between two methods Better visualization of Cormack-Lehane grading between two methods
- Being tested
- Oro Tracheal Intubation by DL, Oro Tracheal Intubation by VL
- Keywords
- Video Laryngoscope, Direct Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oro Tracheal Intubation by DLDevice
DL
Oro Tracheal Intubation by VLDevice
VL
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscopy | Active comparator | All participants who are intubated from Direct laryngoscopy is enrolled in this arm. Receives: Device: Oro Tracheal Intubation by DL |
| Video Laryngoscopy | Experimental | All participants who are intubated from Video laryngoscopy is enrolled in this arm. Receives: Device: Oro Tracheal Intubation by VL |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success of direct laryngoscopy in oro tracheal intubation
success of oro tracheal intubation during DL
Measured: 1 year
First pass success of video laryngoscopy in oro tracheal intubation
success of oro tracheal intubation during VL
Measured: 1 year
Secondary outcomes (3)
Complications rates between two methods.
rate of complication during intubation via DL or VL will be noted
Measured: 1 year
Use of alternative methods for ventilation or oxygenation between two methods
use of alternative methods during intubation via DL or VL will be noted
Measured: 1 year
Better visualization of Cormack-Lehane grading between two methods
better visualization of cormack lehane grading during intubation via DL or VL will be noted
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare Success Rate of Video Laryngoscopy vs Direct LaryngoscopyStudies 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
- Model description
- An open-label, single center, prospective, randomized, comparative, intervention study.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patan Academy of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rony Maharjan, Patan Academy of Health Sciences
- Investigators
- Rony Maharjan, MD, Principal investigator, Patan Academy of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327867
- Sponsor's protocol ID
- drs2402021836
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department
- ClinicalTrials.gov ID
- NCT06327867
- Acronym / sponsor ID
- drs2402021836
- Keywords
- Video Laryngoscope, Direct Laryngoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Patan Academy of Health SciencesUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 25 Mar 2024 (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 is an open-label, single center, prospective, randomized, comparative, intervention study.
The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:
- To assess the adverse events during video laryngoscopy
- To assess the adverse events during direct Laryngoscopy
- To compare the first pass success rate of DL vs VL according to demographic profile (age and sex)
Detailed description
All consecutive patients presenting in Emergency medicine room requiring intubation, will be recruited in this study after taking informed written consent from the patients' family, excluding those falling in exclusion criteria. Direct laryngoscopy will be done by Mackintosh Laryngoscope with blade no 3 or 4. Video Laryngoscopy will be done by Mcgrath Mac Video Laryngoscope in respective groups. Intubations will be done by ER physicians and Emergency fellows of Emergency department. The total number of required sample size will be calculated and the obtained number will be divided in a group of 21 with block of 6 each. After randomizing the group and the block from a computerized software, a total of 21 envelope will be prepared in a consecutive manner and the patient will be intubated as per the pre decided blocks. All the patients in emergency who require intubation and falling into the inclusion criteria will be assessed. Informed written consent will be taken from the patient's family explaining that they will be a part of study and either of the laryngoscopy method will be used in them. Informed consent will be taken by one of the investigators, (ER physicians and emergency medicine fellow) who will be performing intubations in them.Inclusion criteria-
- Age 18 years
- Patient requiring orotracheal intubation
- Those who give written informed consent
Exclusion criteria-
- Pregnancy
- Intubations done by medical officers
Randomization-
- The consecutive patients will be assigned numbers serially from one.
- Block randomization of the patients in two arms will be done by using computerized software.
A total of 63 patients in each arm with total 126 patients will be included in the study. Blocks of 6 will be taken with total 21 groups. With using the software, random group will be selected and intubations will be done accordingly.
Demographic and clinical profile of patients in both arms will be recorded. Two treatment arms-
- Arm A- Orotracheal intubation done by Direct Laryngoscopy
- Arm B- Orotracheal intubation done by Video Laryngoscopy
Outcomes Primary- First pass success of direct laryngoscopy in oro tracheal intubation First pass success of video laryngoscopy in oro tracheal intubation
Secondary- Complications rates between two methods. Use of alternative methods for ventilation or oxygenation between two methods Better visualization of Cormack-Lehane grading between two methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, single center, prospective, randomized, comparative, intervention study.
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscopy | Active comparator | Device: Oro Tracheal Intubation by DLAll participants who are intubated from Direct laryngoscopy is enrolled in this arm. |
| Video Laryngoscopy | Experimental | Device: Oro Tracheal Intubation by VLAll participants who are intubated from Video laryngoscopy is enrolled in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years
- Patient requiring orotracheal intubation
- Those who give written informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Intubations done by medical officers
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 |
|---|---|---|
| Oro Tracheal Intubation by DLDL | Device | Direct Laryngoscopy |
| Oro Tracheal Intubation by VLVL | Device | Video Laryngoscopy |
Primary outcome
First pass success of direct laryngoscopy in oro tracheal intubation
Time frame: 1 year
success of oro tracheal intubation during DL
First pass success of video laryngoscopy in oro tracheal intubation
Time frame: 1 year
success of oro tracheal intubation during VL
3 secondary outcomes
Complications rates between two methods.
Time frame: 1 year
Use of alternative methods for ventilation or oxygenation between two methods
Time frame: 1 year
Better visualization of Cormack-Lehane grading between two methods
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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.
Rony Maharjan, MD principal investigator
Patan Academy of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Oro Tracheal Intubation by DL and Oro Tracheal Intubation by VL in people with To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy, run by Patan Academy of Health Sciences.
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 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Rony Maharjan, MD (9840728187, ronymaharjan@pahs.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success of direct laryngoscopy in oro tracheal intubation (time frame: 1 year). 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?
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 11 Apr 2024.