Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy (FIBERTRACH)

• ClinicalTrials.gov Identifier: NCT04265625
• Recruitment Status: Recruiting
• First Posted: February 11, 2020
• Last Update Posted: September 21, 2023
• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Information provided by (Responsible Party): José Manuel Añón, Instituto de Investigación Hospital Universitario La Paz

Tracking Information

• First Submitted Date: February 5, 2020
• First Posted Date: February 11, 2020
• Last Update Posted Date: September 21, 2023
• Actual Study Start Date: December 7, 2019
• Estimated Primary Completion Date: February 28, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2020)

• Number of patients with bleeding [ Time Frame: 24 hours ]
  Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
• Number of patients with hypoxemia [ Time Frame: During the procedure ]
  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: During the procedure ]
  Loss of airway: Failure to be able to access the airway > 30 seconds.
• Number of patients with atelectasis [ Time Frame: 24 hours ]
  Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.
• Number of patients with hypotension [ Time Frame: During the procedure ]
  Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.
• Number of patients with barotrauma [ Time Frame: 24 hours ]
  Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
• Number of patients with posterior tracheal wall injury [ Time Frame: During the procedure ]
  Posterior tracheal wall injury: Injury to membranous trachea from needle, guide or dilator.
• Number of patients in whom false passage has ocurred [ Time Frame: During the procedure ]
  False passage: Dilatation or insertion of the cannula out of the trachea lumen.

Original Primary Outcome Measures (submitted: February 10, 2020)

• Bleeding [ Time Frame: 24 hours ]
  Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.
• Hypoxemia [ Time Frame: During the procedure ]
  Oxygen arterial saturation (SaO2) < 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia.
• Loss of airway [ Time Frame: During the procedure ]
  Failure to be able to access the airway > 30 seconds.
• Atelectasis [ Time Frame: 24 hours ]
  Total or partial lung collapse not present before the technique, evidenced at postoperative control.
• Hypotension [ Time Frame: During the procedure ]
  Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.
• Barotrauma [ Time Frame: 24 hours ]
  Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.
• Posterior tracheal wall injury [ Time Frame: During the procedure ]
  Injury to membranous trachea from needle, guide or dilator.
• False passage [ Time Frame: During the procedure ]
  Dilatation or insertion of the cannula out of the trachea lumen.

Current Secondary Outcome Measures (submitted: February 10, 2020)

• Peak airway pressure [ Time Frame: During the procedure ]
  Maximum peak airway pressure (cmH2O)
• Plateau pressure [ Time Frame: During the procedure ]
  Maximum plateau pressure (cmH2O)
• Tidal volume [ Time Frame: During the procedure ]
  Minimum tidal volume (mL)
• Arterial Blood Gas [ Time Frame: 2 hours ]
  Arterial blood gase at the beginning and the end of the procedure
• Oxygen saturation (SaO2) [ Time Frame: During the procedure ]
  Minimum arterial oxygen saturation (SaO2)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 10, 2020)

Mortality [ Time Frame: 90 days ]

All-cause mortality at hospital discharge

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy
• Official Title: The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial

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.

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 tracheotomy performed under endoscopic guidance decreases the incidence of perioperative complications of the procedure.

Main goal

1. - To assess the incidence of perioperative complications of percutaneous tracheotomy under endoscopic guide versus blind percutaneous tracheotomy.
2. - 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Tracheostomy Complication

Intervention

Device: endoscopic guidance

Percutaneous tracheotomy performed by endoscopic guidance

Study Arms

• No Intervention: blind tracheotomy
  no endoscopic guidance tracheotomy
• Experimental: endoscopic guidance tracheotomy
  With endoscopic guidance tracheotomy
  Intervention: Device: endoscopic guidance

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 10, 2020): 442
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2024
• Estimated Primary Completion Date: February 28, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jose Manuel Añon, MD, PhD; +(34) 912071307; jmaelizalde@gmail.com

• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04265625
• Other Study ID Numbers: HULP5455
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: José Manuel Añón, Instituto de Investigación Hospital Universitario La Paz
• Original Responsible Party: Same as current
• Current Study Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jose Manuel Añon, MD. PhD; Hospital Universitario La Paz. IdiPAZ

• PRS Account: Instituto de Investigación Hospital Universitario La Paz
• Verification Date: February 2023