<< Go Back

Metadata

Name
Validation of Supra-Sternal Tube-Tip Palpation
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT00690508
Description
Background:

The intra-tracheal intubation of a patient is a most delicate medical procedure performed
under often life-threatening conditions in in- and out-of-hospital acute care medicine.
Correct placement of the tube after intra-tracheal intubation is thus absolutely vital.
Incorrect position of the tube can be fatal through loss of the airway or through barotrauma
of the airway and lungs possibly leading to cardiac arrest. The mid-tracheal point of the
trachea is the perfect place for an intra-tracheal tube to be to guarantee ventilatory
support without problems for neonates and children. Supra-sternal palpation of the tube tip
(SSTTP) is a method validated in newborns only, which has a very high accuracy rate in
placing the tube-tip at the mid-tracheal point. In addition, it is easy to learn and without
side effects. In infants and children, SSTTP is widely used in Switzerland although never
validated in a controlled trial.

Objective:

To validate supra-sternal palpation of the endo-tracheal tube tip as a valuable measure to
correctly determine the depth of intubation in infants from one month of age to children up
to eight years of age, when correct depth of the tube-tip is defined as tube-tip being within
plus/minus 0.25cm of the line between the medial points of the claviculae (IMP) for infants
and within plus/mius 0.25 respectively plus/mius 0.38cm for toddlers and children.

Hypothesis:

Supra-sternal Tube Tip Palpation (SSTTP) is a valid and easy to perform measure to identify
the correct depth of intubation after oral or nasal tracheal intubation in infants, toddlers
and children. Correct depth is defined as tube tip placed within plus/minus 0.25cm of the IMP
for infants and within plus/minus 0.25 respectively plus/minus 0.38cm for toddlers and
children.

Study design and methods:

Sixty-four toddlers and children and 18 infants will be enrolled into the study. Three
Respiratory Therapists (RT) from the Pediatric Intensive Care Unit (PICU) will be trained in
SSTTP before the start of the study. Successful training of the RTs will be confirmed by
x-ray before final qualification as "Expert in SSTTP". All patients with an intubation
requiring a post-manipulation x-ray in the PICU at CHEO will be enrolled into the study. No
randomization will be necessary; all infants and children in need of an intubation will be
enrolled into the study. Potential patients will be excluded if there is presence of
anatomical malformation or any other reason that would prevent accurate SSTTP, or if there is
no Expert in SSTTP available. The location of the tip of the tube after SSTTP will be
measured on standard post-intubation x-rays by a radiologist. The tube-tip location
difference will be calculated as the difference between the actual tube-tip location and the
IMP.
Data or Study Types
clinical trial
Keywords
placement, Validate, SSTTP, corrrect, Intubation, Trachea, Sternum,, Tube tip, Tube placement, Tube tip palpation,, use
Source Organization
Unknown
Access Conditions
available
Year
2008
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT00690508

Distributions