Airtraq Versus Conventional Laryngoscopy in Children
This study has been completed.
Sponsor:
University Hospitals Bristol NHS Foundation Trust
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT01212536
First received: July 15, 2010
Last updated: December 14, 2011
Last verified: December 2011
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Purpose
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.
| Condition | Intervention |
|---|---|
|
Children General Anesthesia Intubation |
Device: Airtraq laryngoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children |
Further study details as provided by University Hospitals Bristol NHS Foundation Trust:
Primary Outcome Measures:
- time taken to successful intubation [ Time Frame: 30 mins ] [ Designated as safety issue: No ]The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace).
Secondary Outcome Measures:
- Grade of laryngoscopy [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
- POGO score [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
- VAS ease of intubation [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
- evidence of traumatic intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | August 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Conventional
conventional laryngoscopy for intubation
|
|
|
Experimental: Airtraq
laryngoscopy with Airtraq for intubation
|
Device: Airtraq laryngoscopy
laryngoscopy and intubation
|
Eligibility| Ages Eligible for Study: | up to 6 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
- Classified by the American Society of Anesthesiology (ASA) as grade 1-3.
- Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.
Exclusion Criteria:
- inability of patient or parents to understand the study or consent process
- known or suspected difficult airway
- ASA 4 and above
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212536
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212536
Locations
| United Kingdom | |
| Bristol Childrens hospital | |
| Bristol, United Kingdom, BS2 8BJ | |
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
Oxford University Hospitals NHS Trust
More Information
| Responsible Party: | Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01212536 History of Changes |
| Other Study ID Numbers: | CH/2009/3387 |
| Study First Received: | July 15, 2010 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United Kingdom: NRES |
Keywords provided by University Hospitals Bristol NHS Foundation Trust:
|
children intubation laryngoscope |
ClinicalTrials.gov processed this record on September 23, 2016