Pediatric Endotracheal IntubationNCT03955094
Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
A study testing Intubation via AMBU® AURAGAIN™ in people with Pediatric Endotracheal Intubation, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study will be conducted as a prospective observational study This study will be done in any of the operating theatres of University Malaya Medical Centre This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation Ambu… Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Endotracheal Intubation
- What is being tested?
- Intubation via AMBU® AURAGAIN™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2019to 30 Apr 2020
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Paediatric patients aged 3 - 12 years old
- American Society of Anaesthesiologist (ASA) 1-2 patients
- Patients must require standard endotracheal intubation for the procedure posted
Who cannot join
- Documented history of difficult airway in previous general anaesthesia
- Clinical features of difficult airway on physical examination
- Syndromic patients, facial deformities, dental deformities, patients with facial trauma
- Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
- Patients with existing pulmonary diseases or any risk of bronchospasm
- Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration
Show all 10Show fewer
- Any other contraindication for device placement
- Operations requiring specialised endotracheal tubes
- Emergency operations or unanticipated difficult airway cases
- Refusal of parental informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
This study will be conducted as a prospective observational study
This study will be done in any of the operating theatres of University Malaya Medical Centre
This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation
Ambu Aura Gain will be used as a conduit for intubation
Read the detailed description
All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded
- Conditions
- Pediatric Endotracheal Intubation
- Being tested
- Intubation via AMBU® AURAGAIN™
- Keywords
- AMBU® AURAGAIN™, intubation in paediatrics, flexible scope guided intubation, success rate of intubation, glottic view, supraglottic airway intubation, efficacy safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation via AMBU® AURAGAIN™Device
Also called AMBU® AURAGAIN™, Supraglottic device
Success rate of paediatric intubation through AMBU® AURAGAIN™
| Study group | Role | What they receive |
|---|---|---|
| AMBU® AURAGAIN™ device | Experimental | Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics Receives: Device: Intubation via AMBU® AURAGAIN™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to successful intubation via the Ambu® AuraGain™
Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing
Measured: Time taken during procedure ( measured in seconds )
Secondary outcomes (1)
Time taken required for removal of Ambu® AuraGain™ post intubation
Successful removal of device is confirmed by equal air entry heard bilaterally on auscultation and a positive capnograph tracing
Measured: Time taken during procedure ( measured in seconds )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lim Su Sian, University of Malaya
- Investigators
- Ismiarti S Ina, MAnaes(UM), Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955094
- Sponsor's protocol ID
- Auragain study
- Status last verified
- Aug 2020
- First submitted
- 8 May 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.
PubMed 21973052Pandey RK, Subramanium RK, Darlong V, Lekha C, Garg R, Punj J, Rewari V, Bajpai M. Evaluation of glottic view through Air-Q Intubating Laryngeal Airway in the supine and lateral position and assessing it as a conduit for blind endotracheal intubation in children in the supine position. Paediatr Anaesth. 2015 Dec;25(12):1241-7. doi: 10.1111/pan.12746. Epub 2015 Sep 29.
PubMed 26417722Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
PubMed 21081777Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
PubMed 22971118Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24.
PubMed 25537736Girgis KK, Youssef MM, ElZayyat NS. Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients. Saudi J Anaesth. 2014 Oct;8(4):470-6. doi: 10.4103/1658-354X.140841.
PubMed 25422603
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
- ClinicalTrials.gov ID
- NCT03955094
- Acronym / sponsor ID
- Auragain study
- Conditions
- Pediatric Endotracheal Intubation
- Keywords
- AMBU® AURAGAIN™, intubation in paediatrics, flexible scope guided intubation, success rate of intubation, glottic view, supraglottic airway intubation, efficacy safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 17 May 2019 (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 study will be conducted as a prospective observational study
This study will be done in any of the operating theatres of University Malaya Medical Centre
This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation
Ambu Aura Gain will be used as a conduit for intubation
Detailed description
All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups
| Arm | Type | Receives |
|---|---|---|
| AMBU® AURAGAIN™ device | Experimental | Device: Intubation via AMBU® AURAGAIN™Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Paediatric patients aged 3 - 12 years old
- American Society of Anaesthesiologist (ASA) 1-2 patients
- Patients must require standard endotracheal intubation for the procedure posted
Key exclusion criteria (10 listed)
- Documented history of difficult airway in previous general anaesthesia
- Clinical features of difficult airway on physical examination
- Syndromic patients, facial deformities, dental deformities, patients with facial trauma
- Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
- Patients with existing pulmonary diseases or any risk of bronchospasm
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 |
|---|---|---|
| Intubation via AMBU® AURAGAIN™Also: AMBU® AURAGAIN™, Supraglottic deviceSuccess rate of paediatric intubation through AMBU® AURAGAIN™ | Device | AMBU® AURAGAIN™ device |
Primary outcome
Time taken to successful intubation via the Ambu® AuraGain™
Time frame: Time taken during procedure ( measured in seconds )
Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing
1 secondary outcome
Time taken required for removal of Ambu® AuraGain™ post intubation
Time frame: Time taken during procedure ( measured in seconds )
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 5 Aug 2020.
- Background: PubMed 21973052Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.
- Background: PubMed 26417722Pandey RK, Subramanium RK, Darlong V, Lekha C, Garg R, Punj J, Rewari V, Bajpai M. Evaluation of glottic view through Air-Q Intubating Laryngeal Airway in the supine and lateral position and assessing it as a conduit for blind endotracheal intubation in children in the supine position. Paediatr Anaesth. 2015 Dec;25(12):1241-7. doi: 10.1111/pan.12746. Epub 2015 Sep 29.
- Background: PubMed 21081777Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.
- Background: PubMed 22971118Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13.
- Background: PubMed 25537736Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24.
- Background: PubMed 25422603Girgis KK, Youssef MM, ElZayyat NS. Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients. Saudi J Anaesth. 2014 Oct;8(4):470-6. doi: 10.4103/1658-354X.140841.
- Individual participant dataSharing planned: No
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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.
Ismiarti S Ina, MAnaes(UM) study chair
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation via AMBU® AURAGAIN™ in people with Pediatric Endotracheal Intubation, run by University of Malaya at 1 site in Malaysia.
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 10 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 5 Aug 2020. 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 Malaysia. 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?
Time taken to successful intubation via the Ambu® AuraGain™ (time frame: Time taken during procedure ( measured in seconds )). 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 NCT03955094, which also lists 6 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 5 Aug 2020.