Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Franz Frei, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01156233
First received: June 30, 2010
Last updated: February 9, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 30, 2010
Last Updated: February 9, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013