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Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

NCT04265625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

  • Complications

Interventions

DEVICE

endoscopic guidance

Percutaneous tracheotomy performed by endoscopic guidance

Sponsors & Collaborators

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Jose Manuel Añon, MD. PhD · Hospital Universitario La Paz. IdiPAZ

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-07
Primary Completion
2024-12-28
Completion
2024-12-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04265625 on ClinicalTrials.gov