Validation of Supra-Sternal Tube-Tip Palpation (SSTTP)
Recruitment status was Recruiting
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.
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Validation of Supra-Sternal Tube-Tip Palpation (SSTTP): A Method to Identify Correct Depth of Intubation in Infants and Children|
- Accuracy of Tube Placement with SSTTP [ Time Frame: acute ] [ Designated as safety issue: No ]
- Ease of performing SSTTP [ Time Frame: acute ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Procedure: Supra-Sternal Tube-Tip Palpation (SSTTP)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690508
|Contact: Uwe Schwarz, M.D., Dr. med.||613-737-7600 ext email@example.com|
|Children's Hospital of Eastern Ontario||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L1|
|Contact: Uwe Schwarz, MD firstname.lastname@example.org|
|Principal Investigator:||Uwe Schwarz, M.D., Dr. med.||Department of Anesthesia, Children's Hospital of Eastern Ontario|