Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy — FIBERTRACH  

Tracheostomy Complication Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tracheostomy Complication

• NCT number: NCT04265625
• Study type: Interventional
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Jose Manuel Añon, MD, PhD
• Phone: +(34) 912071307
• Email: jmaelizalde@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2019
• Completion date: April 30, 2025