Other Tracheostomy ComplicationNCT02802527
Percutaneous Tracheostomy - Systematic Comparison Among Two Methods
A study testing Percutaneous Tracheostomy in people with Other Tracheostomy Complication, run by Hadassah Medical Organization.
Trial summary
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Tracheostomy Complication
- What is being tested?
- Percutaneous Tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to May 2019
- 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
- All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
- Minimal age 18
Who cannot join
- No patient consent for participation
- Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room
About this study
Official title: Percutaneous Tracheostomy - Systematic Comparison Among Two Methods: Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.
So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.
Read the detailed description
Introduction Percutaneous dilatational tracheostomy (PDT) is routinely performed in most intensive care units in the world for a number of indications, such as: airway obstruction, need for long-term respiratory support, improvement in trachea-bronchial toilet, prophylaxis before head and neck procedures, cases of severe obstructive sleep apnea and poor neurological state.
Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical tracheostomy in the operating room.
In many places around the world it is customary to perform the procedure under direct visions via a bronchoscope to prevent damage to adjacent structures, ensure correct position of the tracheostomy tube, avoid damage to the posterior wall of the trachea and to confirm the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment and knowledge and skill of the operator. Use of the bronchoscope during the procedure may also result in complications such as temporary occlusion of the trachea and hypercarbia and increased duration of the procedure. Maintenance of the bronchoscope also carries associated costs (disinfection, replacement, etc.).
A retrospective review of 243 percutaneous tracheostomies done in trauma patients between January 2007 and December 2010 in whom 78 (32%) was performed with a bronchoscope and 168 (68%) without, found no differences between the groups 4.
Another retrospective study 5 looking only at percutaneous tracheostomies done without bronchoscopic guidance, analyzed 300 PDTs showed that 26 patients (8.6%) had complications, including: 2 (0.6%) patients deteriorated neurologically and 2 (0.6%) deaths were observed within 24 h following procedure. The median operating time was 3.5 min (range, 2.5-8 min). There were no cannula placement problems in any case . A retrospective study looking at 512 bronchoscopy guided procedures over 10 years concluded that: Eighteen patients (3.5%) presented procedural complications. Five patients experienced transient desaturation, 4 presented low blood pressure related to sedation, and 9 presented minor bleeding, but none required a transfusion. No serious complications or deaths associated with the procedure were recorded. Eleven patients (2.1%) presented post-operative complications. Seven presented minor and transitory bleeding of the percutaneous tracheostomy stoma, 2 suffered displacement of the tracheostomy cannula, and 2 developed a superficial infection of the stoma.
In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.
So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.
- Conditions
- Other Tracheostomy Complication
- Being tested
- Percutaneous Tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous TracheostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopy Guided | Other | Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire. Receives: Procedure: Percutaneous Tracheostomy |
| Direct Laryngoscopy | Other | Performing percutaneous tracheostomy by placing the tube higher up, near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck. Receives: Procedure: Percutaneous Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A systematic comparison among the two methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity.
Measured: 30 days
Secondary outcomes (4)
Periprocedural Mortality.
Measured: 30 days.
Post procedural ICU & Hospital length of stay.
Measured: 30 days.
Complication rate comparison of PDT done in the ICU to PDT done in locations other than the ICU.
Measured: 30 days.
Procedure's length.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Tracheostomy ComplicationStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802527
- Sponsor's protocol ID
- TRACH- HMO-CTIL
- Status last verified
- Apr 2016
- First submitted
- 13 Apr 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
Publications
Nachshon A, Shapiro A, Goldfarb S, Kuzmina N, Romain M, Schwartz A, Abutbul A, Vilchik I, Beil M, van Heerden PV; Tracheostomy Study Group. The impact of bronchoscopy on the safety of percutaneous tracheostomy: a randomized controlled trial. Crit Care. 2026 Mar 18;30(1):218. doi: 10.1186/s13054-026-05912-2.
PubMed 41851791
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tracheostomy - Systematic Comparison Among Two Methods: Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy
- ClinicalTrials.gov ID
- NCT02802527
- Acronym / sponsor ID
- TRACH- HMO-CTIL
- Conditions
- Other Tracheostomy Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2019 (estimated)
- First posted
- 16 Jun 2016 (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.
Percutaneous tracheostomy is routinely performed in most intensive care units in the world.Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical operation in the operating room.
In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.
So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.
Detailed description
Introduction Percutaneous dilatational tracheostomy (PDT) is routinely performed in most intensive care units in the world for a number of indications, such as: airway obstruction, need for long-term respiratory support, improvement in trachea-bronchial toilet, prophylaxis before head and neck procedures, cases of severe obstructive sleep apnea and poor neurological state.
Several studies have shown that the procedure is safe and economically efficient in comparison to open surgical tracheostomy in the operating room.
In many places around the world it is customary to perform the procedure under direct visions via a bronchoscope to prevent damage to adjacent structures, ensure correct position of the tracheostomy tube, avoid damage to the posterior wall of the trachea and to confirm the final position of the tube. However, the use of a bronchoscope depends on the availability of the equipment and knowledge and skill of the operator. Use of the bronchoscope during the procedure may also result in complications such as temporary occlusion of the trachea and hypercarbia and increased duration of the procedure. Maintenance of the bronchoscope also carries associated costs (disinfection, replacement, etc.).
A retrospective review of 243 percutaneous tracheostomies done in trauma patients between January 2007 and December 2010 in whom 78 (32%) was performed with a bronchoscope and 168 (68%) without, found no differences between the groups 4.
Another retrospective study 5 looking only at percutaneous tracheostomies done without bronchoscopic guidance, analyzed 300 PDTs showed that 26 patients (8.6%) had complications, including: 2 (0.6%) patients deteriorated neurologically and 2 (0.6%) deaths were observed within 24 h following procedure. The median operating time was 3.5 min (range, 2.5-8 min). There were no cannula placement problems in any case . A retrospective study looking at 512 bronchoscopy guided procedures over 10 years concluded that: Eighteen patients (3.5%) presented procedural complications. Five patients experienced transient desaturation, 4 presented low blood pressure related to sedation, and 9 presented minor bleeding, but none required a transfusion. No serious complications or deaths associated with the procedure were recorded. Eleven patients (2.1%) presented post-operative complications. Seven presented minor and transitory bleeding of the percutaneous tracheostomy stoma, 2 suffered displacement of the tracheostomy cannula, and 2 developed a superficial infection of the stoma.
In the investigator's institution as in a number of institutions in the country and abroad, it is acceptable to perform the operation either by withdrawing the endotracheal tube to a position near the vocal cords by direct laryngoscopy and then puncturing the trachea with a needle distal to the endotracheal tube, prior to carrying out the PDT, by location of the anatomy by palpation of the neck, or alternatively by doing the entire procedure under bronchoscopic guidance.
So far, no systematic comparison has been made between the two methods ie PDT without bronchoscopy versus PDT with bronchoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopy Guided | Other | Procedure: Percutaneous TracheostomyPercutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire. |
| Direct Laryngoscopy | Other | Procedure: Percutaneous TracheostomyPerforming percutaneous tracheostomy by placing the tube higher up, near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All intubated patients with various injuries requiring percutaneous tracheostomy (in- house and out- house patients)
- Minimal age 18
Key exclusion criteria (2 listed)
- No patient consent for participation
- Anatomical problem which does not allow for percutaneous tracheostomy and requires open procedure in the operating room
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 |
|---|---|---|
| Percutaneous Tracheostomy | Procedure or surgery | Bronchoscopy Guided, Direct Laryngoscopy |
Primary outcome
A systematic comparison among the two methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity.
Time frame: 30 days
4 secondary outcomes
Periprocedural Mortality.
Time frame: 30 days.
Post procedural ICU & Hospital length of stay.
Time frame: 30 days.
Complication rate comparison of PDT done in the ICU to PDT done in locations other than the ICU.
Time frame: 30 days.
Procedure's length.
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Derived from this study: PubMed 41851791Nachshon A, Shapiro A, Goldfarb S, Kuzmina N, Romain M, Schwartz A, Abutbul A, Vilchik I, Beil M, van Heerden PV; Tracheostomy Study Group. The impact of bronchoscopy on the safety of percutaneous tracheostomy: a randomized controlled trial. Crit Care. 2026 Mar 18;30(1):218. doi: 10.1186/s13054-026-05912-2.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Tracheostomy in people with Other Tracheostomy Complication, run by Hadassah Medical Organization.
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 2 inclusion and 2 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
A systematic comparison among the two methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity. (time frame: 30 days). 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 NCT02802527, which also lists 1 linked publication.
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 16 Jun 2016.