Orotracheal Intubation in Infants Requiring General Anaesthesia for SurgeryNCT03378154
Comparing the Efficacy of King Vision in Infants
A study testing Orotracheal intubation in infants with Macintosh and Orotracheal intubation in infants with King vision in people with Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery, run by Jawaharlal Institute of Postgraduate Medical Education & Research at 1 site in India.
Trial summary
The primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children < 1 year of age? Read more about this study
- Who is it for?
- Ages 1 day to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery
- What is being tested?
- Orotracheal intubation in infants with Macintosh and Orotracheal intubation in infants with King vision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2018to 1 Apr 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 1 day to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients of the age group 0-1 years undergoing elective or emergency surgeries belonging to American Society ofAnaesthesiologists(ASA) physical status classification 1-2 and requiring administration of General Anaesthesia with orotracheal intubation
Who cannot join
- Patients with anticipated difficult airways
- Patients with aspiration risk or requiring Rapid sequence induction (RSI)
- Patients with laryngeal or tracheal pathologies
- Cervical spine injury
- Active respiratory infection or lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intubation Success and Glottis Visualization With King Vision Video Laryngoscope as Compared to Conventional Laryngoscopes in Children < 1 Years: A Randomized Control Trial
The primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children < 1 year of age?
Read the detailed description
Securing the airway by tracheal intubation is one of the most critical steps during administration of general anesthesia to infants. Failure or a delay in tracheal intubation leads to severe hypoxic insult to infants as the oxygen consumption is high in them when compared to adults.Smaller caliber of the pediatric airway, relatively large tongue, anteriorly located larynx, floppy and relatively large epiglottis predispose young children to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places the head and neck in the flexed position when the patient is placed recumbent, further exacerbating airway obstruction
Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations can lead to significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope utilizes indirect laryngoscopy via its camera and helps improve glottic visualization, thereby minimizing complications
New age videolaryngoscopes with their unique design provide better glottis visualization without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby minimizing the complications associated with excessive manipulation and hence provide a decent edge over the conventional indirect laryngoscopes routinely used. With the above mentioned advantages these videolaryngoscopes can be efficiently used in both elective as well as emergencysettings in infants for intubation The investigators in this study will be evaluating the efficacy of King vision video laryngoscope when compared to the conventional laryngoscopes in routine use for infants.
- Being tested
- Orotracheal intubation in infants with Macintosh, Orotracheal intubation in infants with King vision
- Keywords
- King vision, Difficult airway, Videolaryngoscope, Paediatric intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orotracheal intubation in infants with MacintoshProcedure or surgery
Orotracheal intubation in infants using Macintosh laryngoscope
Orotracheal intubation in infants with King visionProcedure or surgery
Orotracheal intubation in infants with King vision videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Tracheal Intubation in infants using Macintosh laryngoscopes | Experimental | Children < 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the Macintosh laryngoscope Receives: Procedure: Orotracheal intubation in infants with Macintosh |
| Tracheal Intubation in infants using King vision | Experimental | Children < 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the King vision videolaryngoscope Receives: Procedure: Orotracheal intubation in infants with King vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt intubation success rate
Comparison of first attempt intubation success rate of King vision videolaryngoscope and the Macintosh laryngoscope in children < 1 year. A total of two laryngoscopy attempts each lasting not more than 60 secs will be allowed. Inability to secure the airway by means of successful orotracheal intubation within the 2 attempts will be taken as a failure. Success rates of both the devices will be compared in the study.
Measured: 0 - 15 minutes
Secondary outcomes (4)
Cormack-Lehane grading (CL grade)
Comparison of Cormack-Lehane grading using King vision and Macintosh laryngoscope. CL grading is a 4 point grading system used to classify the glottic view obtained while performing laryngoscopy (CL 1,2,3,4). A better CL grade obtained is associated with a higher success rate. CL grade obtained with both the devices will be compared in the study.
Measured: 0 - 15 minutes
Percentage of glottic opening score (POGO score)
Comparison of POGO scoring(with and without BURP manuever) using King vision and Macintosh laryngoscope will done in he study
Measured: 0 - 15 minutes
Ease of insertion
Comparison of ease of insertion of King vision and Macintosh laryngoscope will be done based on a 5 point Likert scale.
Measured: 0 - 15 minutes
Mean intubation time
Comparison of Mean intubation time of King vision video laryngoscope and Macintosh laryngoscope in children< 1 year of age. Mean intubation time will be taken as the time between the scope passing the teeth to the appearance of the first end tidal Co2(EtCo2) curve.
Measured: 0 - 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orotracheal Intubation in Infants Requiring General Anaesthesia for SurgeryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Sponsor type
- Other government
- Responsible party
- Principal investigator, M Manov, Jawaharlal Institute of Postgraduate Medical Education & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378154
- Sponsor's protocol ID
- JIP/IEC/2017/0273
- Status last verified
- Apr 2019
- First submitted
- 8 Nov 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shravanalakshmi D, Bidkar PU, Narmadalakshmi K, Lata S, Mishra SK, Adinarayanan S. Comparison of intubation success and glottic visualization using King Vision and C-MAC videolaryngoscopes in patients with cervical spine injuries with cervical immobilization: A randomized clinical trial. Surg Neurol Int. 2017 Feb 6;8:19. doi: 10.4103/2152-7806.199560. eCollection 2017.
PubMed 28217398Sinha 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 27293429Holm-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 19128325
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Success and Glottis Visualization With King Vision Video Laryngoscope as Compared to Conventional Laryngoscopes in Children < 1 Years: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03378154
- Acronym / sponsor ID
- JIP/IEC/2017/0273
- Keywords
- King vision, Difficult airway, Videolaryngoscope, Paediatric intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & ResearchOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Dec 2017 (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 primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children < 1 year of age?
Detailed description
Securing the airway by tracheal intubation is one of the most critical steps during administration of general anesthesia to infants. Failure or a delay in tracheal intubation leads to severe hypoxic insult to infants as the oxygen consumption is high in them when compared to adults.Smaller caliber of the pediatric airway, relatively large tongue, anteriorly located larynx, floppy and relatively large epiglottis predispose young children to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places the head and neck in the flexed position when the patient is placed recumbent, further exacerbating airway obstruction
Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations can lead to significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope utilizes indirect laryngoscopy via its camera and helps improve glottic visualization, thereby minimizing complications
New age videolaryngoscopes with their unique design provide better glottis visualization without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby minimizing the complications associated with excessive manipulation and hence provide a decent edge over the conventional indirect laryngoscopes routinely used. With the above mentioned advantages these videolaryngoscopes can be efficiently used in both elective as well as emergencysettings in infants for intubation The investigators in this study will be evaluating the efficacy of King vision video laryngoscope when compared to the conventional laryngoscopes in routine use for infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal Intubation in infants using Macintosh laryngoscopes | Experimental | Procedure: Orotracheal intubation in infants with MacintoshChildren < 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the Macintosh laryngoscope |
| Tracheal Intubation in infants using King vision | Experimental | Procedure: Orotracheal intubation in infants with King visionChildren < 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the King vision videolaryngoscope |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients of the age group 0-1 years undergoing elective or emergency surgeries belonging to American Society ofAnaesthesiologists(ASA) physical status classification 1-2 and requiring administration of General Anaesthesia with orotracheal intubation
Key exclusion criteria (5 listed)
- Patients with anticipated difficult airways
- Patients with aspiration risk or requiring Rapid sequence induction (RSI)
- Patients with laryngeal or tracheal pathologies
- Cervical spine injury
- Active respiratory infection or lung disease
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 |
|---|---|---|
| Orotracheal intubation in infants with MacintoshOrotracheal intubation in infants using Macintosh laryngoscope | Procedure or surgery | Tracheal Intubation in infants using Macintosh laryngoscopes |
| Orotracheal intubation in infants with King visionOrotracheal intubation in infants with King vision videolaryngoscope | Procedure or surgery | Tracheal Intubation in infants using King vision |
Primary outcome
First attempt intubation success rate
Time frame: 0 - 15 minutes
Comparison of first attempt intubation success rate of King vision videolaryngoscope and the Macintosh laryngoscope in children < 1 year. A total of two laryngoscopy attempts each lasting not more than 60 secs will be allowed. Inability to secure the airway by means of successful orotracheal intubation within the 2 attempts will be taken as a failure. Success rates of both the devices will be compared in the study.
4 secondary outcomes
Cormack-Lehane grading (CL grade)
Time frame: 0 - 15 minutes
Percentage of glottic opening score (POGO score)
Time frame: 0 - 15 minutes
Ease of insertion
Time frame: 0 - 15 minutes
Mean intubation time
Time frame: 0 - 15 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 16 Apr 2019.
- Background: PubMed 28217398Shravanalakshmi D, Bidkar PU, Narmadalakshmi K, Lata S, Mishra SK, Adinarayanan S. Comparison of intubation success and glottic visualization using King Vision and C-MAC videolaryngoscopes in patients with cervical spine injuries with cervical immobilization: A randomized clinical trial. Surg Neurol Int. 2017 Feb 6;8:19. doi: 10.4103/2152-7806.199560. eCollection 2017.
- 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 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orotracheal intubation in infants with Macintosh and Orotracheal intubation in infants with King vision in people with Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery, run by Jawaharlal Institute of Postgraduate Medical Education & Research 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 1 inclusion and 5 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 16 Apr 2019. 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?
First attempt intubation success rate (time frame: 0 - 15 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 NCT03378154, which also lists 3 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 16 Apr 2019.