Tracheal IntubationSSTTPNCT00690508
Validation of Supra-Sternal Tube-Tip Palpation
A study testing Supra-Sternal Tube-Tip Palpation (SSTTP) in people with Tracheal Intubation, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Supra-Sternal Tube-Tip Palpation (SSTTP)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- "Primary intubations":
- All infants and children from 1 month of age up to the end of the seventh year of life, who are being intubated for medical reasons on the pediatric intensive care unit (PICU) at the Children's hospital of Eastern Ontario.
- "Secondary intubations":
- All infants and children from 1 month of age up to the end of the seventh year of life already intubated in the PICU at the Children's Hospital of Eastern Ontario, who's tube needs to be exchanged, who's tube needs to be repositioned according a previous x-ray or who's tube needs any other manipulation requiring a post-manipulation chest x-ray.
Who cannot join
- "Primary, peracute intubations". Intubations required at once or within a few minutes.
- Anatomical malformation of the child's or infant's airway, lungs or neck.
- Tracheostoma, history of tracheotomy, jugular scars or any other reason that might prevent accurate supra-sternal palpation.
- After placement of the tube according to supra-sternal palpation, any difficulties ventilating the patient or endo-bronchial intubation as per auscultation will lead to placement of the tube according to previously used criteria. The case will be described but the patient excluded from determination of the tube tip placement with x-ray.
- Any case when the study procedures had to be discontinued because the treating physician or RT felt that care could be disrupted by virtue of the study procedures. The case will be described but the patient excluded from determination of the tube tip placement with x-ray.
- Unavailability of an expert in SSTTP at the time point of needed intubation.
- For ethical reasons, we will exclude patients who we know will have a detrimental outcome despite intubation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Uwe Schwarz, MD, uschwarz@cheo.on.ca
About this study
Official title: Validation of Supra-Sternal Tube-Tip Palpation (SSTTP): A Method to Identify Correct Depth of Intubation in Infants and Children
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.
Read more
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.
- Conditions
- Tracheal Intubation
- Being tested
- Supra-Sternal Tube-Tip Palpation (SSTTP)
- Keywords
- Intubation, Trachea, Sternum,, Tube tip, Tube placement, Tube tip palpation,, Validate, use, SSTTP, corrrect, placement
- Medical subject headings
- Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra-Sternal Tube-Tip Palpation (SSTTP)Procedure or surgery
The supra-sternal palpation of the tube after tracheal intubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Tube Placement with SSTTP
Measured: acute
Secondary outcomes (1)
Ease of performing SSTTP
Measured: acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Investigators
- Uwe Schwarz, M.D., Dr. med., Principal investigator, Department of Anesthesia, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690508
- Sponsor's protocol ID
- 07/35X
- Acronym
- SSTTP
- Status last verified
- Jun 2008
- First submitted
- 7 Apr 2008
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Supra-Sternal Tube-Tip Palpation (SSTTP): A Method to Identify Correct Depth of Intubation in Infants and Children
- ClinicalTrials.gov ID
- NCT00690508
- Acronym / sponsor ID
- SSTTP / 07/35X
- Conditions
- Tracheal Intubation
- Keywords
- Intubation, Trachea, Sternum,, Tube tip, Tube placement, Tube tip palpation,, Validate, use, SSTTP, corrrect, placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- "Primary intubations":
- "Secondary intubations":
Key exclusion criteria (7 listed)
- "Primary, peracute intubations". Intubations required at once or within a few minutes.
- Anatomical malformation of the child's or infant's airway, lungs or neck.
- Tracheostoma, history of tracheotomy, jugular scars or any other reason that might prevent accurate supra-sternal palpation.
- After placement of the tube according to supra-sternal palpation, any difficulties ventilating the patient or endo-bronchial intubation as per auscultation will lead to placement of the tube according to previously used criteria. The case will be described but the patient excluded from determination of the tube tip placement with x-ray.
- Any case when the study procedures had to be discontinued because the treating physician or RT felt that care could be disrupted by virtue of the study procedures. The case will be described but the patient excluded from determination of the tube tip placement with x-ray.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supra-Sternal Tube-Tip Palpation (SSTTP)The supra-sternal palpation of the tube after tracheal intubation. | Procedure or surgery | – |
Primary outcome
Accuracy of Tube Placement with SSTTP
Time frame: acute
1 secondary outcome
Ease of performing SSTTP
Time frame: acute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
Related trials for Tracheal Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study
Intubation Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Schwarz, M.D., Dr. med. principal investigator
Department of Anesthesia, Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supra-Sternal Tube-Tip Palpation (SSTTP) in people with Tracheal Intubation, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Schwarz, M.D., Dr. med. (613-737-7600 ext. 3010, uschwarz@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Tube Placement with SSTTP (time frame: acute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.