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

February 9, 2013 updated by: Franz Frei

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4005
        • Universitätskinderspital beider Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Pediatric endotracheal tube. Microcuff, Kimberly-Clark.
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 Names:
  • Pediatric endotracheal tube, Microcuff, Kimberly-Clark
Experimental: Withdrawing tube technique
Identification of the tube by withdrawing until good quality breath sounds
Procedure: Anesthesia induction
Cuff palpation technique: identification of the cuff position in the trachea by palpation.
Other Names:
  • Pediatric endotracheal tube. Microcuff, Kimberly-Clark.
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 Names:
  • Pediatric endotracheal tube, Microcuff, Kimberly-Clark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franz Frei

Investigators

  • Principal Investigator: Franz Frei, Professor, University Childrens Hospital beider Basel Postfach CH 4005 Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 9, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKBB_ANA_ TET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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