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Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156233
First Posted: July 2, 2010
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Franz Frei, University Hospital, Basel, Switzerland
  Purpose
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.

Condition Intervention
Intubation, Endotracheal Procedure: Anesthesia induction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques

Resource links provided by NLM:


Further study details as provided by Franz Frei, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Localisation and precision of the tip of the endotracheal tube (TET) in the trachea [ Time Frame: 10 minutes ]
    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.


Enrollment: 69
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cuff palpation technique
Cuff palpation by the investigator's finger.
Procedure: Anesthesia induction
Cuff palpation technique: identification of the cuff position in the trachea by palpation.
Other Name: Pediatric endotracheal tube. Microcuff, Kimberly-Clark.
Experimental: Withdrawing tube technique
Identification of the tube by withdrawing until good quality breath sounds
Procedure: Anesthesia induction
Right mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available.
Other Name: Pediatric endotracheal tube, Microcuff, Kimberly-Clark

Detailed Description:
Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0-4 years
  • ASA I-II
  • requiring endotracheal tube for surgical/diagnostic procedures

Exclusion Criteria:

  • patients with abnormal airway anatomy
  • kyphoscoliosis
  • syndromes known to affect airway anatomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156233


Locations
Switzerland
Universitätskinderspital beider Basel
Basel, Switzerland, 4005
Sponsors and Collaborators
Franz Frei
Investigators
Principal Investigator: Franz Frei, Professor University Childrens Hospital beider Basel Postfach CH 4005 Basel
  More Information

Responsible Party: Franz Frei, Prof. Dr. Franz Frei, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01156233     History of Changes
Other Study ID Numbers: UKBB_ANA_ TET
First Submitted: June 30, 2010
First Posted: July 2, 2010
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Franz Frei, University Hospital, Basel, Switzerland:
evaluating precision of tube tip position with two methods

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs