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

NCT06637280 | Recruiting

• 1 other identifier: 0120-294/2023/3
• Study Type: interventional
• Target: 150
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Hypoxemia During EBUS Bronchoscopy

Keywords

EBUS bronchoscopy; high - flow nasal cannula; oxygenation; desaturation; oxygen supplementation

Outcome Measures

Primary Outcomes (1)

• Number of desaturations during EBUS bronchoscopy

  * Desaturation \<90% for more than 10 seconds * Moderate desaturation 75% \<= SpO2 \<90% less than 60 seconds * Severe desaturation \<75% or 75% \<= SpO2 \<90% more than 60 seconds

  From beginning of EBUS bronchoscopy until the end of the procedure + 10 minutes

Study Arms (2)

Standard nasal cannula 6l/min, 100% O2

ACTIVE COMPARATOR

Standard procedure during EBUS bronchoscopy

Device: Standard nasal cannula

High - flow nasal cannula 60l/min, 45% O2

EXPERIMENTAL

The new method

Device: High - flow nasal cannula

Interventions

High - flow nasal cannula DEVICE

High flow nasal cannula (HFNC), a device first introduced in neonates and pediatric care, is currently used in a wide range of indications in adult respiratory and critical care medicine (5-7). It is a relatively new method in bronchoscopy with several notable theoretical advantages over low flow oxygen via conventional nasal cannula (CNC): * High flow up to 60 liters per minute ensures a more stable FiO2 and better matches the increased patient's inspiratory flow * High flow generates a small positive expiratory airway pressure (up to 5 cm H2O) which could stabilize the upper airways during sedation and have a beneficial effect in the lower airways * High flow reduces dead space in the upper airways and increases alveolar ventilation.

High - flow nasal cannula 60l/min, 45% O2

Standard nasal cannula DEVICE

Standard method for supplementing oxygen during EBUS bronchoscopy

Standard nasal cannula 6l/min, 100% O2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients older than 18 years, ASA I - III, with normal pre-procedural pO2 (\&gt; 8.0 kPa) and pCO2 (\&lt; 6.7 kPa) levels without oxygen supplementation

You may not qualify if:

• \- Patient refuses to participate in the study
• Contraindication for topical anesthesia, iv sedation, or bronchoscopy
• Pregnancy
• Contraindication for HFNC including nasopharyngeal obstruction and blockage
• Patient unable to tolerate HFNC 60l/min (tested before the procedure)
• Procedure shorter than 10 min
• Less than 3 EBUS-TBNAs performed

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead
• National and Kapodistrian University of Athens: collaborator
• Clinical Hospital Centre Zagreb: collaborator
• Universidade Nova de Lisboa: collaborator

Study Sites (4)

University Hospital Centre Zagreb - Jordanovac

Zagreb, City of Zagreb, 1000, Croatia

RECRUITING

National and Kapodistrian University of Athens

Athens, Athens, 106 79, Greece

RECRUITING

Clinica Universitaria de Pneumologia, Hospital de Santa Maria

Lisbon, Lisbon District, 1649-028, Portugal

RECRUITING

University Clinic Golnik

Golnik, Golnik, 4204, Slovenia

RECRUITING

Central Study Contacts

Ales Rozman, MD, PhD

CONTACT

+38641313811; ales.rozman@klinika-golnik.si

Sonja Badovinac, MD, PhD

CONTACT

+385916302152; sonjabadovinac1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, specialist for chest diseases

Model Details: randomised, prospective

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 15, 2024
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: In 2025
• Access Criteria: open access journal preferably

Locations

CR (1); GR (1); PT (1); SL (1)