Clinical trial NCT04265625: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications
Keywords: Percutaneous tracheostomy
Endoscopic guidance
Fiberoptic endoscopic guidance
Complications
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: Number of patients with bleeding
timeFrame: From date of randomization until 24 hours later
measure: Number of patients with hypoxemia
timeFrame: From date of randomization until 24 hours later
measure: Number of patients in whom a loss of airway has ocurred
timeFrame: From randomization until the end of the procedure
measure: Number of patients with atelectasis
timeFrame: From date of randomization until 24 hours later
measure: Number of patients with hypotension
timeFrame: From randomization until the end of the procedure
measure: Number of patients with barotrauma
timeFrame: From date of randomization until 24 hours later
measure: Number of patients with posterior tracheal wall injury
timeFrame: From date of randomization until 24 hours later
measure: Number of patients in whom false passage has ocurred
timeFrame: From randomization until the end of the procedure
measure: Number of patients in whom cardiac arrest or death directly related to any complication arising from the technique occurred
timeFrame: From date of randomization until the ICU discharge
Secondary outcomes:
measure: Peak airway pressure
timeFrame: From randomization until the end of the procedure
measure: Plateau pressure
timeFrame: From randomization until the end of the procedure
measure: Tidal volume
timeFrame: From randomization until the end of the procedure
measure: Arterial Blood Gas
timeFrame: From randomization until 15 minutes after the procedure
measure: Oxygen saturation (SaO2)
timeFrame: From randomization until the end of the procedure
Other outcomes:
measure: Mortality
timeFrame: From the date of randomization until the hospital discharge
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
Study officials:
affiliation: Hospital Universitario La Paz. IdiPAZ
name: Jose Manuel Añon, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.