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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy Complication
• Intervention / Treatment: Device: endoscopic guidance

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
• Enrollment (Estimated): 442
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Manuel Añon, MD, PhD; Phone Number: +(34) 912071307; Email: jmaelizalde@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Jose M. Añon, MD,PhD; Phone Number: +(34) 912071307; Email: jmaelizalde@gmail.com
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Infanta Leonor
    • Contact: Covadonga Rodriguez, MD; Email: covarodriguezruiz@gmail.com
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Rey Juan carlos
    • Contact: Manuel Perez-Marquez, MD; Email: mapemar@msn.com
    • Sub-Investigator: Manuel Perez-Marquez, MD
  • Toledo, Spain
    • Recruiting
    • Hospital Universitario de Toledo
    • Contact: Margarita Marquez, MD; Email: margui1992@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: blind tracheotomy; no endoscopic guidance tracheotomy
Experimental: endoscopic guidance tracheotomy; With endoscopic guidance tracheotomy	Device: endoscopic guidance; Percutaneous tracheotomy performed by endoscopic guidance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality at hospital discharge	90 days

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Jose Manuel Añon, MD. PhD, Hospital Universitario La Paz. IdiPAZ

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2019
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous tracheostomy, Fiberoptic bronchoscopic guidance
• Other Study ID Numbers: HULP5455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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