Tracheostomy HemorrhageNCT01502657
Ultrasound Guided Percutaneous Tracheostomy
A study testing Ultrasonography (EnVisor Philips Medical Systems) in people with Tracheostomy Hemorrhage and Tracheostomy Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Hemorrhage, Tracheostomy Complications, Other Tracheostomy Complications
- What is being tested?
- Ultrasonography (EnVisor Philips Medical Systems)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Dec 2011
- 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 hospitalized in ICU in whom percutaneous tracheostomy is indicated,
- patients aged > 18 years old,
Who cannot join
- age less than 18 years,
- clotting disorder,
- infection at the puncture site,
- emergency tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Percutaneous Tracheostomy in the ICU
The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.
Read the detailed description
Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.
- Being tested
- Ultrasonography (EnVisor Philips Medical Systems)
- Keywords
- percutaneous tracheostomy, ultrasonography, echography, critical care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography (EnVisor Philips Medical Systems)Device
Also called Echograph is EnVisor Philips, N°453561299512 rev A, CE0086
Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure related complications
Complications are: paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
Measured: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes (1)
Procedure time
The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy.
Measured: The time will be calculated at the end of the procedure; an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionDec 2011
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 Tracheostomy HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre grégoire Guinot, MD, Principal investigator, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502657
- Sponsor's protocol ID
- PI10-DR-GUINOT
- Other IDs
- 2010-A00901-38
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2011
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.
PubMed 22390815
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Percutaneous Tracheostomy in the ICU
- ClinicalTrials.gov ID
- NCT01502657
- Acronym / sponsor ID
- PI10-DR-GUINOT
- Keywords
- percutaneous tracheostomy, ultrasonography, echography, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jan 2012 (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 determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.
Detailed description
Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients hospitalized in ICU in whom percutaneous tracheostomy is indicated,
- patients aged > 18 years old,
Key exclusion criteria (4 listed)
- age less than 18 years,
- clotting disorder,
- infection at the puncture site,
- emergency tracheostomy
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 |
|---|---|---|
| Ultrasonography (EnVisor Philips Medical Systems)Also: Echograph is EnVisor Philips, N°453561299512 rev A, CE0086Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance; | Device | – |
Primary outcome
Procedure related complications
Time frame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Complications are: paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
1 secondary outcome
Procedure time
Time frame: The time will be calculated at the end of the procedure; an average of 30 minutes
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 19 Sep 2025.
- Results publication: PubMed 22390815Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.
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.
Pierre grégoire Guinot, MD principal investigator
Centre Hospitalier Universitaire, Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography (EnVisor Philips Medical Systems) in people with Tracheostomy Hemorrhage and Tracheostomy Complications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 4 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 19 Sep 2025. 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 France. 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?
Procedure related complications (time frame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks). 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 NCT01502657, 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 19 Sep 2025.