Respiratory FailureNCT05595707
Expert-Guided Early Tracheostomy Pathway
A study testing Expert-Guided Early Tracheostomy in people with Respiratory Failure and Tracheostomy Complication, run by Denver Health and Hospital Authority at 1 site in Jordan.
Trial summary
The optimal timing of tracheostomy insertion remains uncertain. We hypothesized that a clinical pathway including expert-informed risk assessment regarding predicted duration of mechanical (MV) would enhance the effectiveness of early percutaneous dilatational tracheostomy (PDT) for patients with anticipated prolonged… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Tracheostomy Complication
- What is being tested?
- Expert-Guided Early Tracheostomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJordan
- Study dates
- 2 Jan 2018to 30 Sep 2022
- 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
- Patients undergoing continued MV for 48 or more hours for whom continuation of life-prolonging therapy was indicated
Who cannot join
- Patients at imminent risk of death were included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan
The optimal timing of tracheostomy insertion remains uncertain. We hypothesized that a clinical pathway including expert-informed risk assessment regarding predicted duration of mechanical (MV) would enhance the effectiveness of early percutaneous dilatational tracheostomy (PDT) for patients with anticipated prolonged durations of MV, as reflected by duration of ventilation, complications, and patient-centered outcomes.
Read the detailed description
three-year prospective observational study (2018-2020) at a tertiary care level 1 trauma center (King Hussein Medical Center) in Amman Jordan and 4 affiliated subspecialty hospitals. The study sequentially enrolled all adult patients (>18yo) with critical illness receiving MV in an intensive care unit for 48 hours or longer. Institutional ethical committee clearance for the study was secured.
- Conditions
- Respiratory Failure, Tracheostomy Complication
- Being tested
- Expert-Guided Early Tracheostomy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert-Guided Early TracheostomyOther
Patients judged to be at moderate to high risk of prolonged ventilation(26, 27) were those who had chronic respiratory failure, advanced Effectiveness of an Expert-Guided Early Tracheostomy Pathway Page 6/27 age, thrombocytopenia or coagulopathy, persistent vasopressor shock, requirement for renal replacement therapy, an admission trauma diagnosis amongst other criteria, were included. In the absence of these criteria, a consensus for low risk of prolonged MV was reached. Early PDT, within the first 7 days from intubation, was recommended for patients with a moderate/high risk of prolonged MV (Early Group). Continued MV by ETT was recommend for low-risk patients with the potential for delayed PDT in the event of delayed weaning and liberation (Late Group).
| Study group | Role | What they receive |
|---|---|---|
| Early Percutaneous dilatational tracheostomy | Experimental | PDT reccomended for patients with high risk for prolonged mechanical ventilation. Receives: Other: Expert-Guided Early Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization from admission to ventilator independent discharge
Length of stay in days
Measured: Hospital stay up to 90 days
Secondary outcomes (4)
Easy or Moderately Easy to Wean
Numeric Score
Measured: Hospital stay up to 90 days
Days of ventilation requiring administration of NMB
Fraction of days when patient are mechanically ventilated and received NMB
Measured: Hospital stay up to 90 days
Difference in average and total morphine equivalent dose
Derived dose of morphine equivelants based on potency in mg
Measured: Hospital stay up to 90 days
90 day survival
Survival recorded through 90 days from admission
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start2 Jan 2018
- Primary completion30 Dec 2020
- Study completion30 Sep 2022
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health Medical Center
- Responsible party
- Principal investigator, Ivor Douglas, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595707
- Sponsor's protocol ID
- Trachtime22
- Status last verified
- May 2023
- First submitted
- 9 Oct 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Page 1/27 Effectiveness of an Expert-Guided Early Tracheostomy Pathway for Mechanically Ventilated Critically Ill Adults in Jordan
- ClinicalTrials.gov ID
- NCT05595707
- Acronym / sponsor ID
- Trachtime22
- Conditions
- Respiratory Failure, Tracheostomy Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Denver Health Medical Center
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Oct 2022 (actual)
- 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 optimal timing of tracheostomy insertion remains uncertain. We hypothesized that a clinical pathway including expert-informed risk assessment regarding predicted duration of mechanical (MV) would enhance the effectiveness of early percutaneous dilatational tracheostomy (PDT) for patients with anticipated prolonged durations of MV, as reflected by duration of ventilation, complications, and patient-centered outcomes.
Detailed description
three-year prospective observational study (2018-2020) at a tertiary care level 1 trauma center (King Hussein Medical Center) in Amman Jordan and 4 affiliated subspecialty hospitals. The study sequentially enrolled all adult patients (>18yo) with critical illness receiving MV in an intensive care unit for 48 hours or longer. Institutional ethical committee clearance for the study was secured.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Percutaneous dilatational tracheostomy | Experimental | Other: Expert-Guided Early TracheostomyPDT reccomended for patients with high risk for prolonged mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing continued MV for 48 or more hours for whom continuation of life-prolonging therapy was indicated
Key exclusion criteria (1 listed)
- Patients at imminent risk of death were included
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 |
|---|---|---|
| Expert-Guided Early TracheostomyPatients judged to be at moderate to high risk of prolonged ventilation(26, 27) were those who had chronic respiratory failure, advanced Effectiveness of an Expert-Guided Early Tracheostomy Pathway Page 6/27 age, thrombocytopenia or coagulopathy, persistent vasopressor shock, requirement for renal replacement therapy, an admission trauma diagnosis amongst other criteria, were included. In the absence of these criteria, a consensus for low risk of prolonged MV was reached. Early PDT, within the first 7 days from intubation, was recommended for patients with a moderate/high risk of prolonged MV (Early Group). Continued MV by ETT was recommend for low-risk patients with the potential for delayed PDT in the event of delayed weaning and liberation (Late Group). | Other | Early Percutaneous dilatational tracheostomy |
Primary outcome
Duration of hospitalization from admission to ventilator independent discharge
Time frame: Hospital stay up to 90 days
Length of stay in days
4 secondary outcomes
Easy or Moderately Easy to Wean
Time frame: Hospital stay up to 90 days
Days of ventilation requiring administration of NMB
Time frame: Hospital stay up to 90 days
Difference in average and total morphine equivalent dose
Time frame: Hospital stay up to 90 days
90 day survival
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert-Guided Early Tracheostomy in people with Respiratory Failure and Tracheostomy Complication, run by Denver Health and Hospital Authority at 1 site in Jordan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2023. 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 Jordan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of hospitalization from admission to ventilator independent discharge (time frame: Hospital stay up to 90 days). 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 3 May 2023.