MedDataX Logo

Airtraq Versus Conventional Laryngoscopy in Children

NCT ID: NCT01212536

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children General Anesthesia Intubation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

children intubation laryngoscope

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional

conventional laryngoscopy for intubation

Group Type NO_INTERVENTION

No interventions assigned to this group

Airtraq

laryngoscopy with Airtraq for intubation

Group Type EXPERIMENTAL

Airtraq laryngoscopy

Intervention Type DEVICE

laryngoscopy and intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Airtraq laryngoscopy

laryngoscopy and intubation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle White

Consultant in Paediatric Anaesthesia and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bristol Childrens hospital

Bristol, Bristol, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CH/2009/3387

Identifier Type: -

Identifier Source: org_study_id