NCT01156233

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.6 years

First QC Date

June 30, 2010

Last Update Submit

February 9, 2013

Conditions

Keywords

evaluating precision of tube tip position with two methods

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

EXPERIMENTAL

Cuff palpation by the investigator's finger.

Procedure: Anesthesia induction

Withdrawing tube technique

EXPERIMENTAL

Identification of the tube by withdrawing until good quality breath sounds

Procedure: Anesthesia induction

Interventions

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

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

Eligibility Criteria

Age1 Day - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Universitätskinderspital beider Basel

Basel, Basel, 4005, Switzerland

Location

Study Officials

  • Franz Frei, Professor

    University Childrens Hospital beider Basel Postfach CH 4005 Basel

    PRINCIPAL INVESTIGATOR

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

Locations