Intubation; DifficultNCT02566135

I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

A study testing Tracheal Intubation using I-gel and ventilating bougie and Tracheal Intubation using C-LMA and ventilating bougie in people with Intubation; Difficult, run by Medical College Baroda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Intubation; Difficult
What is being tested?: Tracheal Intubation using I-gel and ventilating bougie and Tracheal Intubation using C-LMA and ventilating bougie
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: No sites listed yet
Study dates: Mar 2014to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

age 18 to 60 years
Gender : either sex
American society of Anaesthesiologist's Physical Status (ASAPS) I and II
Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

Who cannot join

age <18 years and > 60 years
ASAPS III or IV
Obesity body mass index >25
Patients with mouth opening <2cms
Patients with Malampatti grade III and IV
Patients having history of gastro-esophageal reflux disease
Patients with history of inadequate fasting
Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.

About this study

Official title: I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie

Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.

Read the detailed description

SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.

Conditions: Intubation; Difficult
Being tested: Tracheal Intubation using I-gel and ventilating bougie, Tracheal Intubation using C-LMA and ventilating bougie
Keywords: C-LMA, I-gel, ventilating bougie, intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tracheal Intubation using I-gel and ventilating bougieDevice
Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.
Tracheal Intubation using C-LMA and ventilating bougieDevice
Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.

Study groups in NCT02566135
Study group	Role	What they receive
Group-I	Active comparator	Tracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed. Receives: Device: Tracheal Intubation using I-gel and ventilating bougie
Group-C	Active comparator	Tracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed. Receives: Device: Tracheal Intubation using C-LMA and ventilating bougie

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Attempts for I-gel or Classic-LMA Insertions
Measured: 60 seconds
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
Measured: 45 seconds
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
Measured: 30 seconds
Time of Insertion
Measured: 5 minutes
Total Intubation Time
Measured: 5 minutes

Secondary outcomes (3)

Heart Rate
Heart rate to observe at the following time intervals.
1. Base line
2. After induction
3. After dexmedetomidine injection
4. Supraglottic airway insertion
5. Ventilating bougie insertion
6. ETT insertion
7. 3minute after ETT insertion
8. 5 minute after ETT insertion
9. 7 minute after ETT insertion
10. 10 minute after ETT insertion
11. 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.
Measured: 25 minutes
Systolic Blood Pressure
Systolic blood pressure measured at following time intervals.
1. Base line
2. After Dexmedetomidine injection
3. After induction of anaesthesia
4. Supraglottic airway insertion
5. Ventilating bougie insertion
6. ETT insertion
7. 3 minute after ETT insertion
8. 5 minute after ETT insertion
9. 7 minute after ETT insertion
10. 10 minute after ETT insertion
11. 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.
Measured: 25 minutes
Diastolic Blood Pressure
Diastolic blood pressure measured at following time intervals.
1. Base line
2. After Dexmedetomidine injection
3. After Induction
4. Supraglottic airway insertion
5. Ventilating bougie insertion
6. ETT insertion
7. 3 minute after ETT insertion
8. 5 minute after ETT insertion
9. 7 minute after ETT insertion
10. 10 minutes after ETT insertion
11. 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.
Measured: 25 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Feb 2015

First posted2 Oct 2015 (estimated)
Study startMar 2014
Primary completionJan 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intubation; DifficultStudies 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: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02566135
Sponsor's protocol ID: ECR/85/Inst/GJ/2013
Status last verified: Jul 2018
First submitted: 7 Sep 2015
Last updated: 27 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison of supraglottic devices i-gel((R)) and LMA Fastrach((R)) as conduit for endotracheal intubation. Indian J Anaesth. 2014 Jul;58(4):397-402. doi: 10.4103/0019-5049.138969.
PubMed 25197106
Wong DT, Yang JJ, Mak HY, Jagannathan N. Use of intubation introducers through a supraglottic airway to facilitate tracheal intubation: a brief review. Can J Anaesth. 2012 Jul;59(7):704-15. doi: 10.1007/s12630-012-9714-8. Epub 2012 Jun 1.
PubMed 22653838
Singh J, Yadav MK, Marahatta SB, Shrestha BL. Randomized crossover comparison of the laryngeal mask airway classic with i-gel laryngeal mask airway in the management of difficult airway in post burn neck contracture patients. Indian J Anaesth. 2012 Jul;56(4):348-52. doi: 10.4103/0019-5049.100815.
PubMed 23087456

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
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All Intubation; Difficult trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie
ClinicalTrials.gov ID: NCT02566135
Acronym / sponsor ID: ECR/85/Inst/GJ/2013
Conditions: Intubation; Difficult
Keywords: C-LMA, I-gel, ventilating bougie, intubation
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Medical College BarodaUniversity, hospital or other
Study start: Mar 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 2 Oct 2015 (estimated)
Results: Posted 27 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group-I	Active comparator	Device: Tracheal Intubation using I-gel and ventilating bougieTracheal intubation using I-gel and ventilating bougie insertion. In Group-I, following general anaesthesia I-gel is to be inserted, through it ventilating bougie is to be inserted then I-gel is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.
Group-C	Active comparator	Device: Tracheal Intubation using C-LMA and ventilating bougieTracheal intubation using C-LMA and ventilating bougie insertion. In Group-C, following general anaesthesia C-LMA is to be inserted, through it ventilating bougie is to be inserted then C-LMA is to be removed and endotracheal tube is to be railroaded over ventilating bougie. Then ventilating bougie is to be removed.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

age 18 to 60 years
Gender : either sex
American society of Anaesthesiologist's Physical Status (ASAPS) I and II
Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

Key exclusion criteria (8 listed)

age <18 years and > 60 years
ASAPS III or IV
Obesity body mass index >25
Patients with mouth opening <2cms
Patients with Malampatti grade III and IV

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
Tracheal Intubation using I-gel and ventilating bougieFollowing general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.	Device	Group-I
Tracheal Intubation using C-LMA and ventilating bougieFollowing general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.	Device	Group-C

Primary outcome

Number of Attempts for I-gel or Classic-LMA Insertions
Time frame: 60 seconds
Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA
Time frame: 45 seconds
Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie
Time frame: 30 seconds
Time of Insertion
Time frame: 5 minutes
Total Intubation Time
Time frame: 5 minutes

3 secondary outcomes

Heart Rate
Time frame: 25 minutes
Systolic Blood Pressure
Time frame: 25 minutes
Diastolic Blood Pressure
Time frame: 25 minutes

Results and safety

Results posted to the registry on 27 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group-I	29	29
Group-C	29	29

Primary outcome: Number of Attempts for I-gel or Classic-LMA Insertions

Time frame: 60 seconds. Number. Unit: attempt

Measure	Group-I n = 29	Group-C n = 29
1st attempt	25	22
2nd attempt	2	5
3rd attempt	2	2

Group-I vs Group-C: Risk Ratio (RR): 1.4628 (95% CI 0.6401 to 3.3428), p = 0.5033, Chi-squared, Corrected

Primary outcome: Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA

Time frame: 45 seconds. Number. Unit: attempt

Measure	Group-I n = 29	Group-C n = 29
1st attempt	23	24
2nd attempt	6	4
3rd attempt	0	1

Group-I vs Group-C: Risk Ratio (RR): 0.8972 (95% CI 0.4858 to 1.6569), p >0.05, Chi-squared, Corrected

Primary outcome: Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie

Time frame: 30 seconds. Number. Unit: attempt

Measure	Group-I n = 29	Group-C n = 29
1st attempt	29	28
2nd attempt	0	1
3rd attempt	0	0

Group-I vs Group-C: p >0.05, Chi-squared, Corrected

Primary outcome: Time of Insertion

Time frame: 5 minutes. Mean (Standard Deviation). Unit: Seconds

Measure	Group-I n = 29	Group-C n = 29
Supraglottic airway	26.17 (2.25)	44.65 (9.14)
Ventilating bougie	31.51 (8.87)	26.31 (9.25)
ETT	25.58 (4.01)	28.13 (8.31)

Group-I vs Group-C: p <0.0001, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group-I	0 of 29 (0%)	2 of 29 (6.9%)	Not reported
Group-C	0 of 29 (0%)	4 of 29 (13.8%)	Not reported

Limitations and caveats (from the sponsor): The use of fiber optic bronchoscope for confirmation of proper placement of I-gel and C-LMA would have been better. Also One can see the passage of ventilating bougie through I-gel and C-LMA into larynx and trachea.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25197106Kapoor S, Jethava DD, Gupta P, Jethava D, Kumar A. Comparison of supraglottic devices i-gel((R)) and LMA Fastrach((R)) as conduit for endotracheal intubation. Indian J Anaesth. 2014 Jul;58(4):397-402. doi: 10.4103/0019-5049.138969.
Results publication: PubMed 22653838Wong DT, Yang JJ, Mak HY, Jagannathan N. Use of intubation introducers through a supraglottic airway to facilitate tracheal intubation: a brief review. Can J Anaesth. 2012 Jul;59(7):704-15. doi: 10.1007/s12630-012-9714-8. Epub 2012 Jun 1.
Results publication: PubMed 23087456Singh J, Yadav MK, Marahatta SB, Shrestha BL. Randomized crossover comparison of the laryngeal mask airway classic with i-gel laryngeal mask airway in the management of difficult airway in post burn neck contracture patients. Indian J Anaesth. 2012 Jul;56(4):348-52. doi: 10.4103/0019-5049.100815.
Individual participant dataSharing planned: No

Related trials for Intubation; Difficult

Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
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Not yet recruitingObservational study
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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.

Aditi A Dhimar, M.D.(anaes) principal investigator

CDSCO

Questions about this trial

What is this clinical trial studying?

A study testing Tracheal Intubation using I-gel and ventilating bougie and Tracheal Intubation using C-LMA and ventilating bougie in people with Intubation; Difficult, run by Medical College Baroda.

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 4 inclusion and 8 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 27 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Attempts for I-gel or Classic-LMA Insertions (time frame: 60 seconds). The study lists 5 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 NCT02566135, 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 27 Jul 2018.