Airway Clearance ImpairmentNCT07315477
Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy
An observational study of Airway Clearance Impairment and Intubating Conditions, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Every year, approximately 10-15 patients are admitted to the general intensive care unit at our institution who have been intubated for airway protection for various reasons, the main ones being soft tissue infection of the head/neck, anaphylaxis with airway edema, oral and maxillofacial/ENT surgery with airway… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Clearance Impairment, Intubating Conditions
- What is being tested?
- early tracheostomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Feb 2026to 1 Oct 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients aged 18-99 who were admitted to the intensive care unit from January 2012 to November 2025 and ventilated for airway protection for any reason.
Inclusion Criteria: All patients aged 18-99 who were admitted to the intensive care unit from January 2012 to November 2025 and ventilated for airway protection for any reason.
-
Exclusion Criteria:Patients who did not meet the above criteria or patients for whom data was missing.
-
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Meir medical center Kfar Saba
Kfar Saba
Meir Medical Center
Kfar Saba
About this study
Official title: Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy: a Retrospective Study
Every year, approximately 10-15 patients are admitted to the general intensive care unit at our institution who have been intubated for airway protection for various reasons, the main ones being soft tissue infection of the head/neck, anaphylaxis with airway edema, oral and maxillofacial/ENT surgery with airway threat, and head/neck injury with airway threat. Some patients are successfully extubated after the acute condition that caused the need for ventilation in the first place has passed, and some require tracheostomy for reasons related to the primary disease (unresolved edema, continued infectious process, need for additional invasive interventions, etc.) or for reasons related to difficulty in respiratory weaning (poor awakening, muscle weakness, development of respiratory infection, etc.).
We would like to examine whether it is possible to characterize certain parameters in the above patient population that are associated with a higher likelihood of requiring tracheostomy during hospitalization (such as age Adult). In these cases, we may consider performing the tracheostomy earlier.
- Conditions
- Airway Clearance Impairment, Intubating Conditions
- Being tested
- early tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early tracheostomyProcedure or surgery
early tracheostomy
| Study group | Role | What they receive |
|---|---|---|
| Patients intubated due to impending airway obstruction | Not described Receives: Procedure: early tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subgroup of patients with highest need for tracheostomy
Subgroup with highest precentage of tracheostomy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Clearance ImpairmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315477
- Sponsor's protocol ID
- MMC-0269-25
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients Intubated for Airway Protection in the Intensive Care Unit and Timing of Tracheostomy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07315477
- Acronym / sponsor ID
- MMC-0269-25
- Conditions
- Airway Clearance Impairment, Intubating Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 2 Jan 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.
Every year, approximately 10-15 patients are admitted to the general intensive care unit at our institution who have been intubated for airway protection for various reasons, the main ones being soft tissue infection of the head/neck, anaphylaxis with airway edema, oral and maxillofacial/ENT surgery with airway threat, and head/neck injury with airway threat. Some patients are successfully extubated after the acute condition that caused the need for ventilation in the first place has passed, and some require tracheostomy for reasons related to the primary disease (unresolved edema, continued infectious process, need for additional invasive interventions, etc.) or for reasons related to difficulty in respiratory weaning (poor awakening, muscle weakness, development of respiratory infection, etc.).
We would like to examine whether it is possible to characterize certain parameters in the above patient population that are associated with a higher likelihood of requiring tracheostomy during hospitalization (such as age Adult). In these cases, we may consider performing the tracheostomy earlier.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients intubated due to impending airway obstruction | – | Procedure: early tracheostomy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients aged 18-99 who were admitted to the intensive care unit from January 2012 to November 2025 and ventilated for airway protection for any reason.
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 tracheostomy | Procedure or surgery | Patients intubated due to impending airway obstruction |
Primary outcome
Subgroup of patients with highest need for tracheostomy
Time frame: 1 year
Subgroup with highest precentage of tracheostomy
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 9 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Clearance Impairment and Intubating Conditions, run by Meir Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 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 2 sites in Israel. 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?
Subgroup of patients with highest need for tracheostomy (time frame: 1 year). 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 9 Oct 2026.