|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 7, 2008 | ||||
| Last Updated Date | June 2, 2008 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Accuracy of Tube Placement with SSTTP [ Time Frame: acute ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00690508 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Ease of performing SSTTP [ Time Frame: acute ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of Supra-Sternal Tube-Tip Palpation | ||||
| Official Title ICMJE | Validation of Supra-Sternal Tube-Tip Palpation (SSTTP): A Method to Identify Correct Depth of Intubation in Infants and Children | ||||
| Brief Summary | 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. |
||||
| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Tracheal Intubation | ||||
| Intervention ICMJE | Procedure: Supra-Sternal Tube-Tip Palpation (SSTTP) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | January 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 1 Month to 8 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00690508 | ||||
| Responsible Party | Uwe Schwarz, M.D., Dr. med, Children's Hospital of Eastern Ontario | ||||
| Study ID Numbers ICMJE | 07/35X | ||||
| Study Sponsor ICMJE | University of Ottawa | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Ottawa | ||||
| Verification Date | June 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||