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CompletedNCT01156233Updated Feb 12, 2013

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

An interventional study of Anesthesia induction and Anesthesia induction in Intubation, Endotracheal, sponsored by Franz Frei. Completed at 1 site in Switzerland. Open to participants aged 1 Day to 4 Years. Per ClinicalTrials.gov, last updated 2013-02-12.

Sponsored by Franz Frei · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
1 Day to 4 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Intubation, Endotracheal

Keywords

  • evaluating precision of tube tip position with two methods
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In context

Lead sponsor

This is the only study on the registry with Franz Frei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with abnormal airway anatomy
  • kyphoscoliosis
  • syndromes known to affect airway anatomy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Cuff palpation technique

    Cuff palpation by the investigator's finger.

    Procedure: Anesthesia induction

  • Experimental
    Withdrawing tube technique

    Identification of the tube by withdrawing until good quality breath sounds

    Procedure: Anesthesia induction

Interventions

  • ProcedureAnesthesia induction

    Cuff palpation technique: identification of the cuff position in the trachea by palpation.

    Also known as: Pediatric endotracheal tube. Microcuff, Kimberly-Clark.

  • ProcedureAnesthesia 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.

    Also known as: Pediatric endotracheal tube, Microcuff, Kimberly-Clark

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What researchers measure

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.

    Time frame: 10 minutes

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Study locations

1 site
  • Universitätskinderspital beider Basel
    Basel, Basel 4005, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01156233
Lead sponsor
Franz Frei
Responsible party
Franz Frei (Prof. Dr. Franz Frei, University Hospital, Basel, Switzerland) — Sponsor-investigator
First posted
Jul 2, 2010
Start date
May 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Feb 12, 2013

Study contacts

Franz Frei, Professor
principal investigator · University Childrens Hospital beider Basel Postfach CH 4005 Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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