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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blind tracheotomy | No Intervention | no endoscopic guidance tracheotomy | |
| endoscopic guidance tracheotomy | Experimental | With endoscopic guidance tracheotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic guidance | Device | Percutaneous tracheotomy performed by endoscopic guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with bleeding | Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells. | 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. | 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. | 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. | 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. | From randomization until the end of the procedure |
| Number of patients with barotrauma | Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique. | From date of randomization until 24 hours later |
| Number of patients with posterior tracheal wall injury |
| Measure | Description | Time Frame |
|---|---|---|
| Peak airway pressure | Maximum peak airway pressure (cmH2O) | From randomization until the end of the procedure |
| Plateau pressure | Maximum plateau pressure (cmH2O) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality at hospital discharge | From the date of randomization until the hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Manuel Añon, MD. PhD | Hospital Universitario La Paz. IdiPAZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | 28046 | Spain | |||
| Hospital Universitario Infanta Leonor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34187554 | Background | 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. | |
| 41757863 |
| Label | URL |
|---|---|
| https://pubmed.ncbi.nlm.nih.gov/34187554/ | View source |
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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)
| 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. | 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 | From date of randomization until the ICU discharge |
| From randomization until the end of the procedure |
| Tidal volume | Minimum tidal volume (mL) | From randomization until the end of the procedure |
| Arterial Blood Gas | Arterial blood gase at the beginning and the end of the procedure | From randomization until 15 minutes after the procedure |
| Oxygen saturation (SaO2) | Minimum arterial oxygen saturation (SaO2) | From randomization until the end of the procedure |
| Madrid |
| Spain |
| Hospital Universitario Rey Juan Carlos | Madrid | Spain |
| Hospital Universitario de Toledo | Toledo | Spain |
| Derived |
| Anon 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. |