Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-07

Study Completion Date

2024-12-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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blind tracheotomy

no endoscopic guidance tracheotomy

Group Type NO_INTERVENTION

No interventions assigned to this group

endoscopic guidance tracheotomy

With endoscopic guidance tracheotomy

Group Type EXPERIMENTAL

endoscopic guidance

Intervention Type DEVICE

Percutaneous tracheotomy performed by endoscopic guidance

Interventions

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endoscopic guidance

Percutaneous tracheotomy performed by endoscopic guidance

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No