Head InjuryNCT07872865
Outcomes of Early Versus Late Tracheostomy in Critically Ill Patients Due to Head Injury: A Randomized Controlled Trial
A study testing Tracheostomy in people with Head Injury and Traumatic Brain Injury, run by University Of Anbar at 1 site in Iraq.
Trial summary
Tracheostomy is a surgical procedure that involves creating an opening in the trachea and bringing it to the skin surface to form a stoma. It may be performed as an emergency or elective operation. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Head Injury, Traumatic Brain Injury
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 7 Jan 2026to 25 Sep 2026
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥10 years.
- Isolated traumatic head injury (blunt or penetrating), or traumatic head injury associated with other trauma.
- Expected to require invasive mechanical ventilation for at least 72 hours, as judged by the treating intensivist or neurosurgeon.
- Endotracheal intubation performed during the current hospital admission.
- Enrollment within 48 hours of ICU admission.
Who cannot join
- Prior tracheostomy during the same hospital admission.
- Irreversible brain injury with anticipated withdrawal of life-sustaining treatment within 72 hours.
- Uncorrectable coagulopathy precluding tracheostomy, including platelet count <50 × 10^9/L despite transfusion or INR >1.8 despite correction.
- Uncontrolled intracranial hypertension prohibiting safe positioning for tracheostomy despite optimal management.
- High cervical spine instability contraindicating positioning for tracheostomy, based on neurosurgical assessment.
- Known pregnancy.
- Enrollment in a conflicting interventional trial.
- Prisoners or other vulnerable groups as defined by local regulations.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
University of Anbar, College of Medicine
Ramadi, Al-Anbar Governorate, 31001
About this study
Tracheostomy is a surgical procedure that involves creating an opening in the trachea and bringing it to the skin surface to form a stoma. It may be performed as an emergency or elective operation. The main indications include relief of upper airway obstruction, protection of the lower respiratory tract, and facilitation of assisted ventilation in critically ill patients. Further studies are needed to identify the patient populations that may benefit from early tracheostomy. Therefore, this study was conducted to evaluate early tracheostomy (≤7 days) compared with late tracheostomy (>7 days) in relation to the occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, length of hospital stay, and 30-day mortality in critically ill patients with traumatic head injury.
Read the detailed description
This study was a prospective, randomized, parallel-group, open-label controlled trial conducted among critically ill adult patients with traumatic brain injury requiring invasive mechanical ventilation.
Eligible participants were randomly assigned in a 1:1 ratio to either an early tracheostomy group or a late tracheostomy group. In the early tracheostomy group, tracheostomy was performed within 7 days of endotracheal intubation. In the late tracheostomy group, tracheostomy was performed more than 7 days after endotracheal intubation.
Due to the nature of the intervention, blinding of participants, treating physicians, and other care providers was not feasible. Both groups otherwise received standard intensive care and traumatic brain injury management according to the clinical protocols of the treating institution.
The primary outcome was the occurrence of ventilator-associated pneumonia during ICU admission. Secondary outcomes were 30-day all-cause mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay.
Clinical and demographic information was collected using standardized data collection forms. Recorded variables included participant characteristics, severity of traumatic brain injury, Glasgow Coma Scale score, relevant radiological and clinical findings, timing of tracheostomy, occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and mortality status.
A total of 100 participants were included in the final study population. Outcomes were compared between the early and late tracheostomy groups using appropriate statistical methods for continuous and categorical variables. Statistical significance was defined as a P value of less than 0.05.
The study was conducted following approval from the responsible ethical review authority, and informed consent was obtained from the participant or legally authorized representative as applicable.
- Conditions
- Head Injury, Traumatic Brain Injury
- Being tested
- Tracheostomy
- Keywords
- Early tracheostomy, Late tracheostomy, Tracheostomy, Critically ill patients, Head injury, traumatic brain injury, Tracheostomy Timing, Ventilator-associated pneumonia
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
Tracheostomy performed in critically ill patients with traumatic brain injury according to randomized assignment to either early tracheostomy within 7 days of endotracheal intubation or late tracheostomy after 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Early tracheostomy | Experimental | Participants with traumatic brain injury assigned to undergo tracheostomy within 7 days of endotracheal intubation. Receives: Procedure: Tracheostomy |
| Late tracheostomy | Active comparator | Participants with traumatic brain injury assigned to undergo tracheostomy more than 7 days after endotracheal intubation. Receives: Procedure: Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-Associated Pneumonia
Ventilator-associated pneumonia was assessed from 48 hours after endotracheal intubation until ICU discharge, death, or 30 days after intubation, whichever occurred first.
Measured: Up to 30 days after ICU admission.
Secondary outcomes (4)
30-Day All-Cause Mortality
Proportion of participants who died from any cause within 30 days after tracheostomy.
Measured: 30 days after tracheostomy.
ICU Length of Stay
Number of days from ICU admission until ICU discharge or death.
Measured: Up to 30 days after ICU admission.
Duration of Mechanical Ventilation
number of days from initiation of invasive mechanical ventilation until successful liberation from mechanical ventilation or death.
Measured: Up to 30 days after endotracheal intubation.
Hospital Length of Stay
Number of days from hospital admission until hospital discharge or death.
Measured: Up to 30 days after hospital admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start7 Jan 2026
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies 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
- Model description
- Participants were randomly assigned to either early tracheostomy or late tracheostomy groups and were followed in parallel to compare clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Anbar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raid M. Al-Ani, University Of Anbar
- Investigators
- Raid M Al-Ani, FIBMS, Principal investigator, University of Anbar, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872865
- Sponsor's protocol ID
- SRC-2
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terragni P, Faggiano C, Martin EL, Ranieri VM. Tracheostomy in mechanical ventilation. Semin Respir Crit Care Med. 2014 Aug;35(4):482-91. doi: 10.1055/s-0034-1383862. Epub 2014 Aug 11.
PubMed 25111644Boni A, Tonietto TA, Rihl MF, Viana MV. Early versus late tracheostomy in critically ill patients: an umbrella review of systematic reviews of randomised clinical trials with meta-analyses and trial sequential analysis. BMJ Open Respir Res. 2025 Apr 5;12(1):e002434. doi: 10.1136/bmjresp-2024-002434.
PubMed 40187743Dempsey GA, Morton B, Hammell C, Williams LT, Tudur Smith C, Jones T. Long-Term Outcome Following Tracheostomy in Critical Care: A Systematic Review. Crit Care Med. 2016 Mar;44(3):617-28. doi: 10.1097/CCM.0000000000001382.
PubMed 26584197Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154.
PubMed 23695482
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Versus Late Tracheostomy in Critically Ill Patients Due to Head Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07872865
- Acronym / sponsor ID
- SRC-2
- Conditions
- Head Injury, Traumatic Brain Injury
- Keywords
- Early tracheostomy, Late tracheostomy, Tracheostomy, Critically ill patients, Head injury, traumatic brain injury, Tracheostomy Timing, Ventilator-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Of AnbarUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 14 Oct 2026 (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.
Tracheostomy is a surgical procedure that involves creating an opening in the trachea and bringing it to the skin surface to form a stoma. It may be performed as an emergency or elective operation. The main indications include relief of upper airway obstruction, protection of the lower respiratory tract, and facilitation of assisted ventilation in critically ill patients. Further studies are needed to identify the patient populations that may benefit from early tracheostomy. Therefore, this study was conducted to evaluate early tracheostomy (≤7 days) compared with late tracheostomy (>7 days) in relation to the occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, length of hospital stay, and 30-day mortality in critically ill patients with traumatic head injury.
Detailed description
This study was a prospective, randomized, parallel-group, open-label controlled trial conducted among critically ill adult patients with traumatic brain injury requiring invasive mechanical ventilation.
Eligible participants were randomly assigned in a 1:1 ratio to either an early tracheostomy group or a late tracheostomy group. In the early tracheostomy group, tracheostomy was performed within 7 days of endotracheal intubation. In the late tracheostomy group, tracheostomy was performed more than 7 days after endotracheal intubation.
Due to the nature of the intervention, blinding of participants, treating physicians, and other care providers was not feasible. Both groups otherwise received standard intensive care and traumatic brain injury management according to the clinical protocols of the treating institution.
The primary outcome was the occurrence of ventilator-associated pneumonia during ICU admission. Secondary outcomes were 30-day all-cause mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay.
Clinical and demographic information was collected using standardized data collection forms. Recorded variables included participant characteristics, severity of traumatic brain injury, Glasgow Coma Scale score, relevant radiological and clinical findings, timing of tracheostomy, occurrence of ventilator-associated pneumonia, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and mortality status.
A total of 100 participants were included in the final study population. Outcomes were compared between the early and late tracheostomy groups using appropriate statistical methods for continuous and categorical variables. Statistical significance was defined as a P value of less than 0.05.
The study was conducted following approval from the responsible ethical review authority, and informed consent was obtained from the participant or legally authorized representative as applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either early tracheostomy or late tracheostomy groups and were followed in parallel to compare clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Early tracheostomy | Experimental | Procedure: TracheostomyParticipants with traumatic brain injury assigned to undergo tracheostomy within 7 days of endotracheal intubation. |
| Late tracheostomy | Active comparator | Procedure: TracheostomyParticipants with traumatic brain injury assigned to undergo tracheostomy more than 7 days after endotracheal intubation. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥10 years.
- Isolated traumatic head injury (blunt or penetrating), or traumatic head injury associated with other trauma.
- Expected to require invasive mechanical ventilation for at least 72 hours, as judged by the treating intensivist or neurosurgeon.
- Endotracheal intubation performed during the current hospital admission.
- Enrollment within 48 hours of ICU admission.
Key exclusion criteria (8 listed)
- Prior tracheostomy during the same hospital admission.
- Irreversible brain injury with anticipated withdrawal of life-sustaining treatment within 72 hours.
- Uncorrectable coagulopathy precluding tracheostomy, including platelet count <50 × 10^9/L despite transfusion or INR >1.8 despite correction.
- Uncontrolled intracranial hypertension prohibiting safe positioning for tracheostomy despite optimal management.
- High cervical spine instability contraindicating positioning for tracheostomy, based on neurosurgical assessment.
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 |
|---|---|---|
| TracheostomyTracheostomy performed in critically ill patients with traumatic brain injury according to randomized assignment to either early tracheostomy within 7 days of endotracheal intubation or late tracheostomy after 7 days. | Procedure or surgery | Early tracheostomy, Late tracheostomy |
Primary outcome
Ventilator-Associated Pneumonia
Time frame: Up to 30 days after ICU admission.
Ventilator-associated pneumonia was assessed from 48 hours after endotracheal intubation until ICU discharge, death, or 30 days after intubation, whichever occurred first.
4 secondary outcomes
30-Day All-Cause Mortality
Time frame: 30 days after tracheostomy.
ICU Length of Stay
Time frame: Up to 30 days after ICU admission.
Duration of Mechanical Ventilation
Time frame: Up to 30 days after endotracheal intubation.
Hospital Length of Stay
Time frame: Up to 30 days after hospital admission.
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 14 Oct 2026.
- Results publication: PubMed 25111644Terragni P, Faggiano C, Martin EL, Ranieri VM. Tracheostomy in mechanical ventilation. Semin Respir Crit Care Med. 2014 Aug;35(4):482-91. doi: 10.1055/s-0034-1383862. Epub 2014 Aug 11.
- Results publication: PubMed 40187743Boni A, Tonietto TA, Rihl MF, Viana MV. Early versus late tracheostomy in critically ill patients: an umbrella review of systematic reviews of randomised clinical trials with meta-analyses and trial sequential analysis. BMJ Open Respir Res. 2025 Apr 5;12(1):e002434. doi: 10.1136/bmjresp-2024-002434.
- Results publication: PubMed 26584197Dempsey GA, Morton B, Hammell C, Williams LT, Tudur Smith C, Jones T. Long-Term Outcome Following Tracheostomy in Critical Care: A Systematic Review. Crit Care Med. 2016 Mar;44(3):617-28. doi: 10.1097/CCM.0000000000001382.
- Results publication: PubMed 23695482Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154.
- Comparison of Outcomes of Early Versus Late Tracheostomy in the Treatment of Mechanically Ventilated Critically ill PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Head Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
Raid M Al-Ani, FIBMS principal investigator
University of Anbar, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy in people with Head Injury and Traumatic Brain Injury, run by University Of Anbar at 1 site in Iraq.
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 8 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 14 Oct 2026. 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 Iraq. 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?
Ventilator-Associated Pneumonia (time frame: Up to 30 days after ICU admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07872865, which also lists 4 linked publications.
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 14 Oct 2026.