RecruitingNot ApplicableNCT06637280

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

HFNC Versus Conventional Nasal Cannula During EBUS Procedure: a Randomised Controlled Trial


Sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Enrollment

150 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria7

  • \- 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

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Interventions

DEVICEHigh - flow nasal cannula

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.

DEVICEStandard nasal cannula

Standard method for supplementing oxygen during EBUS bronchoscopy


Locations(4)

University Hospital Centre Zagreb - Jordanovac

Zagreb, City of Zagreb, Croatia

National and Kapodistrian University of Athens

Athens, Athens, Greece

Clinica Universitaria de Pneumologia, Hospital de Santa Maria

Lisbon, Lisbon District, Portugal

University Clinic Golnik

Golnik, Golnik, Slovenia

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NCT06637280