Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques
Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques
1 other identifier
interventional
69
1 country
1
Brief Summary
In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 30, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 12, 2013
February 1, 2013
1.6 years
June 30, 2010
February 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Localisation and precision of the tip of the endotracheal tube (TET) in the trachea
The study intends to determine the location and precision of the TET within the trachea that results from the use of two techniques. The measurements take place after the induction of the anesthesia and before surgery.
10 minutes
Study Arms (2)
Cuff palpation technique
EXPERIMENTALCuff palpation by the investigator's finger.
Withdrawing tube technique
EXPERIMENTALIdentification of the tube by withdrawing until good quality breath sounds
Interventions
Cuff palpation technique: identification of the cuff position in the trachea by palpation.
Eligibility Criteria
You may qualify if:
- Age 0-4 years
- ASA I-II
- requiring endotracheal tube for surgical/diagnostic procedures
You may not qualify if:
- patients with abnormal airway anatomy
- kyphoscoliosis
- syndromes known to affect airway anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Franz Freilead
Study Sites (1)
Universitätskinderspital beider Basel
Basel, Basel, 4005, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Franz Frei, Professor
University Childrens Hospital beider Basel Postfach CH 4005 Basel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Franz Frei
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 2, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 12, 2013
Record last verified: 2013-02