Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT06436196
Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients
A study testing Video Laryngoscope and Direct laryngoscope in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial summary
The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways. The primary outcome measures include: 1. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Video Laryngoscope and Direct laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 30 Jan 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients of age between 2 - 8 years,
- American Society of Anesthesiologist (ASA) grades I-II Children
- Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.
Who cannot join
- Patients with abnormal airway anatomy,
- Obese patients,
- Emergency surgery,
- Congenital syndrome involving any major organs
- Patients' guardians unwilling to participate .
- Patients in whom airway is not secured with a specific technique even after three attempts.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Millitary Hospital
Rawalpindi, Punjab Province, 46000
Muhammad Munim Ilyas, MBBS, 03335642984, munim_95@hotmail.com
About this study
Official title: Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes
The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.
The primary outcome measures include:
- Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
- Rate of complications and failed attempts compared between both modalities.
Read the detailed description
The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.
PROCEDURE:
After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.
If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.
MATERIALS:
Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.
- Being tested
- Video Laryngoscope, Direct laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopeDevice
Use of Video laryngoscope to secure airway
Direct laryngoscopeDevice
Macintosh or Miller's laryngoscopes used to secure paediatric airways
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscopy Group | Active comparator | Group of patients in which standard direct laryngoscopy will be used to secure airway. Receives: Device: Direct laryngoscope |
| Video Laryngoscopy group | Active comparator | Group of patients in which Video Laryngoscopy will be used to secure airways. Receives: Device: Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
.Time taken to acheive the best possible view of the glottis.
The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.
Measured: 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
Time taken to acheive succesful Endotracheal Intubation.
The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.
Measured: 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
No. of Intubation attempts needed
Total No. of attempts(max 3 attempts with the same technique) to secure airway.
Measured: 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
Secondary outcomes (2)
Hemodynamic changes at different intervals.
Changes in heart rate will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
Measured: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Hemodynamic changes at different intervals.
Changes in blood pressure will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
Measured: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 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 Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies 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
- Comparitive study between 2 groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ilyas, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436196
- Sponsor's protocol ID
- CMH/614
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The outcomes of the study will be shared eventually once concluded
Publications
Rabiner JE, Auerbach M, Avner JR, Daswani D, Khine H. Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Intubation of a Pediatric Simulator by Novice Physicians. Emerg Med Int. 2013;2013:407547. doi: 10.1155/2013/407547. Epub 2013 Oct 31.
PubMed 24288617Sinha R, Sharma A, Ray BR, Kumar Pandey R, Darlong V, Punj J, Chandralekha C, Upadhyay AD. Comparison of the Success of Two Techniques for the Endotracheal Intubation with C-MAC Video Laryngoscope Miller Blade in Children: A Prospective Randomized Study. Anesthesiol Res Pract. 2016;2016:4196813. doi: 10.1155/2016/4196813. Epub 2016 May 15.
PubMed 27293429Myatra SN, Patwa A, Divatia JV. Videolaryngoscopy for all intubations: Is direct laryngoscopy obsolete? Indian J Anaesth. 2022 Mar;66(3):169-173. doi: 10.4103/ija.ija_234_22. Epub 2022 Mar 24. No abstract available.
PubMed 35497693Zhou M, Xi X, Li M, Wang S, Liu Z, Liu JQ. Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. Front Pediatr. 2020 Aug 6;8:445. doi: 10.3389/fped.2020.00445. eCollection 2020.
PubMed 32850555
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes
- ClinicalTrials.gov ID
- NCT06436196
- Acronym / sponsor ID
- CMH/614
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 31 May 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.
The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.
The primary outcome measures include:
- Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
- Rate of complications and failed attempts compared between both modalities.
Detailed description
The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.
PROCEDURE:
After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.
If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.
MATERIALS:
Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparitive study between 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscopy Group | Active comparator | Device: Direct laryngoscopeGroup of patients in which standard direct laryngoscopy will be used to secure airway. |
| Video Laryngoscopy group | Active comparator | Device: Video LaryngoscopeGroup of patients in which Video Laryngoscopy will be used to secure airways. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients of age between 2 - 8 years,
- American Society of Anesthesiologist (ASA) grades I-II Children
- Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Patients with abnormal airway anatomy,
- Obese patients,
- Emergency surgery,
- Congenital syndrome involving any major organs
- Patients' guardians unwilling to participate .
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 |
|---|---|---|
| Video LaryngoscopeUse of Video laryngoscope to secure airway | Device | Video Laryngoscopy group |
| Direct laryngoscopeMacintosh or Miller's laryngoscopes used to secure paediatric airways | Device | Direct Laryngoscopy Group |
Primary outcome
.Time taken to acheive the best possible view of the glottis.
Time frame: 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.
Time taken to acheive succesful Endotracheal Intubation.
Time frame: 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.
No. of Intubation attempts needed
Time frame: 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
Total No. of attempts(max 3 attempts with the same technique) to secure airway.
2 secondary outcomes
Hemodynamic changes at different intervals.
Time frame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Hemodynamic changes at different intervals.
Time frame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 24288617Rabiner JE, Auerbach M, Avner JR, Daswani D, Khine H. Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Intubation of a Pediatric Simulator by Novice Physicians. Emerg Med Int. 2013;2013:407547. doi: 10.1155/2013/407547. Epub 2013 Oct 31.
- Background: PubMed 27293429Sinha R, Sharma A, Ray BR, Kumar Pandey R, Darlong V, Punj J, Chandralekha C, Upadhyay AD. Comparison of the Success of Two Techniques for the Endotracheal Intubation with C-MAC Video Laryngoscope Miller Blade in Children: A Prospective Randomized Study. Anesthesiol Res Pract. 2016;2016:4196813. doi: 10.1155/2016/4196813. Epub 2016 May 15.
- Background: PubMed 35497693Myatra SN, Patwa A, Divatia JV. Videolaryngoscopy for all intubations: Is direct laryngoscopy obsolete? Indian J Anaesth. 2022 Mar;66(3):169-173. doi: 10.4103/ija.ija_234_22. Epub 2022 Mar 24. No abstract available.
- Background: PubMed 32850555Zhou M, Xi X, Li M, Wang S, Liu Z, Liu JQ. Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. Front Pediatr. 2020 Aug 6;8:445. doi: 10.3389/fped.2020.00445. eCollection 2020.
- Individual participant dataSharing planned: Yes. The outcomes of the study will be shared eventually once concluded
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscope and Direct laryngoscope in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Watim Medical & Dental College 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 6 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 31 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ilyas, FCPS,MBBS (03007355742, med-spec@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
.Time taken to acheive the best possible view of the glottis. (time frame: 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration). 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 NCT06436196, 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 31 May 2024.