Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06637280

High - Flow Nasal Cannula Versus Conventional Nasal Cannula During Endobronchial Ultrasound Procedure

Led by The University Clinic of Pulmonary and Allergic Diseases Golnik · Updated on 2024-10-15

150

Participants Needed

4

Research Sites

35 weeks

Total Duration

On this page

Sponsors

T

The University Clinic of Pulmonary and Allergic Diseases Golnik

Lead Sponsor

N

National and Kapodistrian University of Athens

Collaborating Sponsor

AI-Summary

What this Trial Is About

EBUS bronchoscopy is performed in most centers under local anesthesia and moderate sedation. Both the bronchoscopy itself and the sedation can lead to decreased ventilation and a drop in oxygen saturation in the body. Typically, oxygen is administered during the procedure via a nasal cannula at a flow rate of 6l/min. The aim of the study is to compare a new method - a nasal cannula with high flow - to the standard cannula. The primary objective is to demonstrate that the new method is more effective at preventing desaturation during the procedure. Patients will be randomized into two groups before bronchoscopy and monitored. The bronchoscopy will be performed in the same way for both groups. The only difference between the groups will be in the method of oxygen administration during EBUS bronchoscopy.

CONDITIONS

Official Title

High - Flow Nasal Cannula Versus Conventional Nasal Cannula During Endobronchial Ultrasound Procedure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years
  • ASA physical status classification I to III
  • Normal pre-procedural oxygen level (pO2 > 8.0 kPa) without oxygen supplementation
  • Normal pre-procedural carbon dioxide level (pCO2 < 6.7 kPa) without oxygen supplementation
Not Eligible

You will not qualify if you...

  • Patient refuses to participate in the study
  • Contraindication for topical anesthesia, intravenous sedation, or bronchoscopy
  • Pregnancy
  • Contraindication for high-flow nasal cannula including nasopharyngeal obstruction or blockage
  • Unable to tolerate high-flow nasal cannula at 60 liters per minute (tested before procedure)
  • Procedure duration shorter than 10 minutes
  • Fewer than 3 EBUS-TBNA procedures performed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University Hospital Centre Zagreb - Jordanovac

Zagreb, City of Zagreb, Croatia, 1000

Actively Recruiting

2

National and Kapodistrian University of Athens

Athens, Athens, Greece, 106 79

Actively Recruiting

3

Clinica Universitaria de Pneumologia, Hospital de Santa Maria

Lisbon, Lisbon District, Portugal, 1649-028

Actively Recruiting

4

University Clinic Golnik

Golnik, Golnik, Slovenia, 4204

Actively Recruiting

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Research Team

A

Ales Rozman, MD, PhD

CONTACT

S

Sonja Badovinac, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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