Respiratory FailureNCT00292097
A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
A study testing Early tracheostomy and Late tracheostomy in people with Respiratory Failure and Traumatic Brain Injury, run by Memorial Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Traumatic Brain Injury
- What is being tested?
- Early tracheostomy and Late tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury
- mechanically ventilated by endotracheal intubation
- projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8
- informed consent obtained from patient or legal representative
Who cannot join
- less than 18 years of age
- projected to need ventilation support for less than 14 days
- anatomical deformity of the neck, including thyromegaly and cervical tumors
- previous tracheostomy
- uncontrolled coagulopathy
- existence of platelet count less than 50,000/mm2
Show all 12Show fewer
- anti-platelet agents
- clinical evidence of ongoing infection at the proposed tracheostomy site as per physician
- mechanical ventilation with a positive end-expiratory pressure greater than 12 cm H20
- intubated more than 72 hours
- patient has undergone cricothyroidotomy
- cricoid cartilage, trachea, or sternal notch not palpable with neck in position
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Medical Center
Johnstown, Pennsylvania, 15905
About this study
Official title: A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury
The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.
Read the detailed description
This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients.
The primary efficacy parameter will be the number of days on mechanical ventilation.
Secondary objectives include:
- Number of days in the hospital
- To assess the incidence of ventilator-acquired pneumonia in each group
- To assess the incidence of accidental extubation in each group
- To assess the incidence of death in each group
- Conditions
- Respiratory Failure, Traumatic Brain Injury
- Being tested
- Early tracheostomy, Late tracheostomy
- Keywords
- Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury
- Medical subject headings
- Respiratory Insufficiency, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early tracheostomyProcedure or surgery
early conversion - less than or equal to 72 hours
Late tracheostomyProcedure or surgery
Late conversion (10-14 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury Receives: Procedure: Early tracheostomy |
| 2 | Active comparator | Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury Receives: Procedure: Late tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of mechanical ventilation days
Measured: until discharged
Secondary outcomes (4)
Total number of hospital days
Measured: until discharged
Incidence of ventilator-associated pneumonia
Measured: until discharged
Incidence of accidental extubation
Measured: until discharged
Incidence of death
Measured: until discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Difficulty obtaining enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Russell D Dumire, MD, Principal investigator, Memorial Medical CenterStephen L Miller, MD, Principal investigator, Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292097
- Sponsor's protocol ID
- MMC 05-27
- Status last verified
- Jun 2008
- First submitted
- 13 Feb 2006
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury
- ClinicalTrials.gov ID
- NCT00292097
- Acronym / sponsor ID
- MMC 05-27
- Conditions
- Respiratory Failure, Traumatic Brain Injury
- Keywords
- Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty obtaining enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Memorial Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Feb 2006 (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.
The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.
Detailed description
This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients.
The primary efficacy parameter will be the number of days on mechanical ventilation.
Secondary objectives include:
- Number of days in the hospital
- To assess the incidence of ventilator-acquired pneumonia in each group
- To assess the incidence of accidental extubation in each group
- To assess the incidence of death in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Early tracheostomyEarly conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury |
| 2 | Active comparator | Procedure: Late tracheostomyConventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury
- mechanically ventilated by endotracheal intubation
- projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8
- informed consent obtained from patient or legal representative
Key exclusion criteria (12 listed)
- less than 18 years of age
- projected to need ventilation support for less than 14 days
- anatomical deformity of the neck, including thyromegaly and cervical tumors
- previous tracheostomy
- uncontrolled coagulopathy
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 |
|---|---|---|
| Early tracheostomyearly conversion - less than or equal to 72 hours | Procedure or surgery | 1 |
| Late tracheostomyLate conversion (10-14 days) | Procedure or surgery | 2 |
Primary outcome
Total number of mechanical ventilation days
Time frame: until discharged
4 secondary outcomes
Total number of hospital days
Time frame: until discharged
Incidence of ventilator-associated pneumonia
Time frame: until discharged
Incidence of accidental extubation
Time frame: until discharged
Incidence of death
Time frame: until discharged
Results and safety
The study was stopped early (reason given: Difficulty obtaining enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
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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.
Russell D Dumire, MD principal investigator
Memorial Medical Center
Stephen L Miller, MD principal investigator
Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early tracheostomy and Late tracheostomy in people with Respiratory Failure and Traumatic Brain Injury, run by Memorial Medical Center at 1 site in United States.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 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 United States. 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?
The study was stopped early (reason given: Difficulty obtaining enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of mechanical ventilation days (time frame: until discharged). 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 5 Jun 2008.