Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

Tracheostomy Complication Clinical Trial

— FIBERTRACH  

Official title:

The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265625
• Other study ID #: HULP5455
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Jose Manuel Añon, MD, PhD
• Phone: +(34) 912071307
• Email: jmaelizalde[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 442
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy Complication

Intervention

Device:
• endoscopic guidance
Percutaneous tracheotomy performed by endoscopic guidance

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Madrid
Spain	Hospital Universitario de Toledo	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	All-cause mortality at hospital discharge	90 days
Primary	Number of patients with bleeding	Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells.	24 hours
Primary	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
Primary	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
Primary	Number of patients with atelectasis	Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control.	24 hours
Primary	Number of patients with hypotension	Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure.	During the procedure
Primary	Number of patients with barotrauma	Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique.	24 hours
Primary	Number of patients with posterior tracheal wall injury	Posterior tracheal wall injury: Injury to membranous trachea from needle, guide or dilator.	During the procedure
Primary	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	Peak airway pressure	Maximum peak airway pressure (cmH2O)	During the procedure
Secondary	Plateau pressure	Maximum plateau pressure (cmH2O)	During the procedure
Secondary	Tidal volume	Minimum tidal volume (mL)	During the procedure
Secondary	Arterial Blood Gas	Arterial blood gase at the beginning and the end of the procedure	2 hours
Secondary	Oxygen saturation (SaO2)	Minimum arterial oxygen saturation (SaO2)	During the procedure

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