ComplicationsFIBERTRACHNCT04265625
Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy
A study testing endoscopic guidance in people with Complications, run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in Spain.
Trial summary
Tracheostomy is one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complications
- What is being tested?
- endoscopic guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 4 sitesSpain
- Study dates
- 7 Dec 2019to 28 Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old requiring tracheotomy due to prolonged mechanical ventilation
- That Family members or legal representatives have signed the information sheet and informed consent
Who cannot join
- Patients with increased intracranial pressure according to intracranial pressure monitoring or suspected.
- Patients who have any absolute or relative contraindication for the percutaneous tracheostomy realization
- Patients with difficult airway
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Rey Juan Carlos
Madrid
Hospital Universitario de Toledo
Toledo
About this study
Official title: The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial
Tracheostomy is one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. However, for others, endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during PT in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the results of six published nation surveys. Extensive randomized trials to compare PT with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis: Percutaneous tracheotomy performed under endoscopic guide decreases the incidence of perioperative complications of the procedure.
Read the detailed description
Background
Tracheostomy is one of the most frequently performed techniques in intensive care units (ICU). A few years after the description of the percutaneous dilatational tracheostomy (PDT), endoscopic guide as part of the technique was performed in four patients. The authors concluded that the endoscopic guide provided advantages to the realization of PDT. Other authors have state that endoscopy, significantly reduces the incidence of serious complications such as posterior tracheal tears, false passage, pneumothorax and subcutaneous emphysema. However, currently endoscopic guide as part of the percutaneous tracheostomy is controversial. Although for some authors its use reduces the number of complications, others found that endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. Thus, some do not consider it necessary when the physicians have enough experience with percutaneous tracheostomy. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during percutaneous tracheostomy in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the published surveys. Specifically, in Spain its use was the lowest of the six published nation surveys. Extensive randomized trials to compare percutaneous tracheostomy with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis
Percutaneous tracheostomy performed under endoscopic control does not reduce the incidence of perioperative complications of the procedure in critically ill patients when it is performed by experienced physicians in patients without anatomical abnormalities.
Main goal
- - To assess the incidence of perioperative complications of percutaneous tracheotomy under endoscopic guide versus blind percutaneous tracheotomy.
- - To assess the ventilatory parameters during percutaneous tracheostomy with and without endoscopic control.
Methodology
Prospective, multicenter randomized study. Patients admitted to the ICU who need tracheostomy due to prolonged mechanical ventilation, who do not have neither contraindications to perform the percutaneous technique nor contraindications to perform fibrobronchoscopy will be randomized.
The percutaneous tracheostomy will be carried out with the single-step dilation method. For its realization, the usual protocol will be followed.
The included patients will be randomized 1:1 (percutaneous tracheostomy with endoscopic guide vs percutaneous tracheostomy without endoscopic guide). The randomization system will be by closed envelope. A sample size of 221 patients in each branch has been calculated.
The percutaneous tracheostomy and fiberoptic bronchoscopy will be performed by staff with experience with both procedures.
- Conditions
- Complications
- Being tested
- endoscopic guidance
- Keywords
- Percutaneous tracheostomy, Endoscopic guidance, Fiberoptic endoscopic guidance, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic guidanceDevice
Percutaneous tracheotomy performed by endoscopic guidance
| Study group | Role | What they receive |
|---|---|---|
| blind tracheotomy | No intervention | no endoscopic guidance tracheotomy |
| endoscopic guidance tracheotomy | Experimental | With endoscopic guidance tracheotomy Receives: Device: endoscopic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bleeding
Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
Measured: From date of randomization until 24 hours later
Number of patients with hypoxemia
Hypoxemia: Oxygen arterial saturation (SaO2) < 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia.
Measured: From date of randomization until 24 hours later
Number of patients in whom a loss of airway has ocurred
Loss of airway: Failure to be able to access the airway > 30 seconds.
Measured: From randomization until the end of the procedure
Number of patients with atelectasis
Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.
Measured: From date of randomization until 24 hours later
Number of patients with hypotension
Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.
Measured: From randomization until the end of the procedure
Number of patients with barotrauma
Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
Measured: From date of randomization until 24 hours later
Number of patients with posterior tracheal wall injury
Posterior tracheal wall injury: Injury to membranous trachea by the needle, guide or dilator along with any related consequences (pneumomediastinum, pneumothorax, subcutaneous emphysema, tracheo-esophageal fistula)
Measured: From date of randomization until 24 hours later
Number of patients in whom false passage has ocurred
False passage: Dilatation or insertion of the cannula out of the trachea lumen.
Measured: From randomization until the end of the procedure
Number of patients in whom cardiac arrest or death directly related to any complication arising from the technique occurred
Cardiac arrest or death
Measured: From date of randomization until the ICU discharge
Secondary outcomes (5)
Peak airway pressure
Maximum peak airway pressure (cmH2O)
Measured: From randomization until the end of the procedure
Plateau pressure
Maximum plateau pressure (cmH2O)
Measured: From randomization until the end of the procedure
Tidal volume
Minimum tidal volume (mL)
Measured: From randomization until the end of the procedure
Arterial Blood Gas
Arterial blood gase at the beginning and the end of the procedure
Measured: From randomization until 15 minutes after the procedure
Oxygen saturation (SaO2)
Minimum arterial oxygen saturation (SaO2)
Measured: From randomization until the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start7 Dec 2019
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Añón, Instituto de Investigación Hospital Universitario La Paz
- Investigators
- Jose Manuel Añon, MD. PhD, Principal investigator, Hospital Universitario La Paz. IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265625
- Sponsor's protocol ID
- HULP5455
- Acronym
- FIBERTRACH
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2020
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anon JM, Arellano MS, Perez-Marquez M, Diaz-Alvarino C, Marquez-Alonso JA, Rodriguez-Pelaez J, Nanwani-Nanwani K, Martin-Pellicer A, Civantos B, Lopez-Fernandez A, Seises I, Garcia-Nerin J, Figueira JC, Casero H, Vejo J, Agrifoglio A, Cachafeiro L, Diaz-Almiron M, Villar J. The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial. Trials. 2021 Jun 29;22(1):423. doi: 10.1186/s13063-021-05370-x.
PubMed 34187554Anon JM, Figueira JC, Civantos B, Agrifoglio A, Marquez M, Rodriguez P, Perez-Marquez M, Rodriguez C, Garcia-Gigorro R, Escuela MP, Garcia-Munoz A, Rodriguez-Pelaez J, Hernandez M, Arellano MS, Dalorzo M, Munoz M, Quesada B, Jimenez G, Fernandez I, Diaz-Alvarino C, Lopez-Fernandez A, Manzanares J, Cachafeiro L, Perales E, Millan P, Sanchez M, Asensio MJ, Vejo J, Diaz-Almiron M, Villar J; FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH) trial investigators. Fiberoptic Bronchoscopy Monitoring During Percutaneous Dilatational Tracheostomy: A Multicenter, Randomized, Controlled Trial. The FIBERTRACH Randomized Clinical Trial. Crit Care Med. 2026 May 1;54(5):1124-1135. doi: 10.1097/CCM.0000000000007078. Epub 2026 Feb 26.
PubMed 41757863
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04265625
- Acronym / sponsor ID
- FIBERTRACH / HULP5455
- Conditions
- Complications
- Keywords
- Percutaneous tracheostomy, Endoscopic guidance, Fiberoptic endoscopic guidance, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 11 Feb 2020 (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 one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. However, for others, endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during PT in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the results of six published nation surveys. Extensive randomized trials to compare PT with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis: Percutaneous tracheotomy performed under endoscopic guide decreases the incidence of perioperative complications of the procedure.
Detailed description
Background
Tracheostomy is one of the most frequently performed techniques in intensive care units (ICU). A few years after the description of the percutaneous dilatational tracheostomy (PDT), endoscopic guide as part of the technique was performed in four patients. The authors concluded that the endoscopic guide provided advantages to the realization of PDT. Other authors have state that endoscopy, significantly reduces the incidence of serious complications such as posterior tracheal tears, false passage, pneumothorax and subcutaneous emphysema. However, currently endoscopic guide as part of the percutaneous tracheostomy is controversial. Although for some authors its use reduces the number of complications, others found that endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. Thus, some do not consider it necessary when the physicians have enough experience with percutaneous tracheostomy. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during percutaneous tracheostomy in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the published surveys. Specifically, in Spain its use was the lowest of the six published nation surveys. Extensive randomized trials to compare percutaneous tracheostomy with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial.
Hypothesis
Percutaneous tracheostomy performed under endoscopic control does not reduce the incidence of perioperative complications of the procedure in critically ill patients when it is performed by experienced physicians in patients without anatomical abnormalities.
Main goal
- - To assess the incidence of perioperative complications of percutaneous tracheotomy under endoscopic guide versus blind percutaneous tracheotomy.
- - To assess the ventilatory parameters during percutaneous tracheostomy with and without endoscopic control.
Methodology
Prospective, multicenter randomized study. Patients admitted to the ICU who need tracheostomy due to prolonged mechanical ventilation, who do not have neither contraindications to perform the percutaneous technique nor contraindications to perform fibrobronchoscopy will be randomized.
The percutaneous tracheostomy will be carried out with the single-step dilation method. For its realization, the usual protocol will be followed.
The included patients will be randomized 1:1 (percutaneous tracheostomy with endoscopic guide vs percutaneous tracheostomy without endoscopic guide). The randomization system will be by closed envelope. A sample size of 221 patients in each branch has been calculated.
The percutaneous tracheostomy and fiberoptic bronchoscopy will be performed by staff with experience with both procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blind tracheotomy | No intervention | –no endoscopic guidance tracheotomy |
| endoscopic guidance tracheotomy | Experimental | Device: endoscopic guidanceWith endoscopic guidance tracheotomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old requiring tracheotomy due to prolonged mechanical ventilation
- That Family members or legal representatives have signed the information sheet and informed consent
Key exclusion criteria (3 listed)
- Patients with increased intracranial pressure according to intracranial pressure monitoring or suspected.
- Patients who have any absolute or relative contraindication for the percutaneous tracheostomy realization
- Patients with difficult airway
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 |
|---|---|---|
| endoscopic guidancePercutaneous tracheotomy performed by endoscopic guidance | Device | endoscopic guidance tracheotomy |
Primary outcome
Number of patients with bleeding
Time frame: From date of randomization until 24 hours later
Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
Number of patients with hypoxemia
Time frame: From date of randomization until 24 hours later
Hypoxemia: Oxygen arterial saturation (SaO2) < 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia.
Number of patients in whom a loss of airway has ocurred
Time frame: From randomization until the end of the procedure
Loss of airway: Failure to be able to access the airway > 30 seconds.
Number of patients with atelectasis
Time frame: From date of randomization until 24 hours later
Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.
Number of patients with hypotension
Time frame: From randomization until the end of the procedure
Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.
Number of patients with barotrauma
Time frame: From date of randomization until 24 hours later
Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
Number of patients with posterior tracheal wall injury
Time frame: From date of randomization until 24 hours later
Posterior tracheal wall injury: Injury to membranous trachea by the needle, guide or dilator along with any related consequences (pneumomediastinum, pneumothorax, subcutaneous emphysema, tracheo-esophageal fistula)
Number of patients in whom false passage has ocurred
Time frame: From randomization until the end of the procedure
False passage: Dilatation or insertion of the cannula out of the trachea lumen.
Number of patients in whom cardiac arrest or death directly related to any complication arising from the technique occurred
Time frame: From date of randomization until the ICU discharge
Cardiac arrest or death
5 secondary outcomes
Peak airway pressure
Time frame: From randomization until the end of the procedure
Plateau pressure
Time frame: From randomization until the end of the procedure
Tidal volume
Time frame: From randomization until the end of the procedure
Arterial Blood Gas
Time frame: From randomization until 15 minutes after the procedure
Oxygen saturation (SaO2)
Time frame: From randomization until the end of the procedure
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 11 Feb 2025.
- Background: PubMed 34187554Anon JM, Arellano MS, Perez-Marquez M, Diaz-Alvarino C, Marquez-Alonso JA, Rodriguez-Pelaez J, Nanwani-Nanwani K, Martin-Pellicer A, Civantos B, Lopez-Fernandez A, Seises I, Garcia-Nerin J, Figueira JC, Casero H, Vejo J, Agrifoglio A, Cachafeiro L, Diaz-Almiron M, Villar J. The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial. Trials. 2021 Jun 29;22(1):423. doi: 10.1186/s13063-021-05370-x.
- Derived from this study: PubMed 41757863Anon JM, Figueira JC, Civantos B, Agrifoglio A, Marquez M, Rodriguez P, Perez-Marquez M, Rodriguez C, Garcia-Gigorro R, Escuela MP, Garcia-Munoz A, Rodriguez-Pelaez J, Hernandez M, Arellano MS, Dalorzo M, Munoz M, Quesada B, Jimenez G, Fernandez I, Diaz-Alvarino C, Lopez-Fernandez A, Manzanares J, Cachafeiro L, Perales E, Millan P, Sanchez M, Asensio MJ, Vejo J, Diaz-Almiron M, Villar J; FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH) trial investigators. Fiberoptic Bronchoscopy Monitoring During Percutaneous Dilatational Tracheostomy: A Multicenter, Randomized, Controlled Trial. The FIBERTRACH Randomized Clinical Trial. Crit Care Med. 2026 May 1;54(5):1124-1135. doi: 10.1097/CCM.0000000000007078. Epub 2026 Feb 26.
- https://pubmed.ncbi.nlm.nih.gov/34187554/Link provided by the sponsor.
- 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.
Jose Manuel Añon, MD. PhD principal investigator
Hospital Universitario La Paz. IdiPAZ
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic guidance in people with Complications, run by Instituto de Investigación Hospital Universitario La Paz at 4 sites in Spain.
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 3 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Number of patients with bleeding (time frame: From date of randomization until 24 hours later). The study lists 9 primary outcomes in all. 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 NCT04265625, which also lists 2 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 11 Feb 2025.