Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

NCT04265625 | Completed DMC

• 1 other identifier: HULP5455
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Complications

Keywords

Percutaneous tracheostomy; Endoscopic guidance; Fiberoptic endoscopic guidance; Complications

Outcome Measures

Primary Outcomes (9)

• 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

  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

Secondary Outcomes (5)

• Peak airway pressure

  From randomization until the end of the procedure

• Plateau pressure

  From randomization until the end of the procedure

• Tidal volume

  From randomization until the end of the procedure

• Arterial Blood Gas

  From randomization until 15 minutes after the procedure

• Oxygen saturation (SaO2)

  From randomization until the end of the procedure

Other Outcomes (1)

• Mortality

  From the date of randomization until the hospital discharge

Study Arms (2)

blind tracheotomy

NO INTERVENTION

no endoscopic guidance tracheotomy

endoscopic guidance tracheotomy

EXPERIMENTAL

With endoscopic guidance tracheotomy

Device: endoscopic guidance

Interventions

endoscopic guidance DEVICE

Percutaneous tracheotomy performed by endoscopic guidance

endoscopic guidance tracheotomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (4)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Rey Juan Carlos

Madrid, Spain

Location

Hospital Universitario de Toledo

Toledo, Spain

Location

Related Publications (1)

• 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.

  PMID: 34187554 BACKGROUND

Related Links

• https://pubmed.ncbi.nlm.nih.gov/34187554/

Study Officials

• Jose Manuel Añon, MD. PhD

  Hospital Universitario La Paz. IdiPAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 11, 2020
• Study Start: December 7, 2019
• Primary Completion: December 28, 2024
• Study Completion: December 28, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)