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

Intubation, Endotracheal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156233
• Other study ID #: UKBB_ANA_ TET
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: February 9, 2013
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation, Endotracheal

Intervention

Procedure:
• Anesthesia induction
Cuff palpation technique: identification of the cuff position in the trachea by palpation.
• 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.

Locations

Country	Name	City	State
Switzerland	Universitätskinderspital beider Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Franz Frei

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes