Ventilatory Effects of THRIVE During EBUS

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

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2024-08-08

Brief Summary

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High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.

This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.

A randomized, double-blinded, cross-over study is designed.

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Detailed Description

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Conditions

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Hypercapnia Sedation Complication High Flow Nasal Cannula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.

Study Groups

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30 L - 70 L

Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 30L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 70 L/min for another 15 minutes.

Group Type ACTIVE_COMPARATOR

THRIVE (High Flow Nasal Cannula)

Intervention Type DEVICE

2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen

70 L - 30 L

Initially, all patients will receive 3L/min of oxygen for 10 minutes. Than, patients in this arm will receive 70L/min of High Flow Nasal Oxygen for 15 minutes and subsequently 30 L/min for another 15 minutes.

Group Type ACTIVE_COMPARATOR

THRIVE (High Flow Nasal Cannula)

Intervention Type DEVICE

2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen

Interventions

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THRIVE (High Flow Nasal Cannula)

2 different rates of nasal flow compared to each other and a baseline of level of nasal oxygen

Intervention Type DEVICE

Other Intervention Names

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THRIVE Optiflow High Flow Nasal Cannula High Flow Nasal Oxygen

Eligibility Criteria

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Inclusion Criteria

* Adult patients with COPD Gold classification 3 or 4
* Scheduled EBUS with sedation

Exclusion Criteria

* Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré.
* Allergy or intolerance for propofol or esketamine
* Severe pulmonary hypertension (PAPsyst \> 60 mmHg)
* Pregnancy
* upper airway obstruction, such as subglottic stenosis or obstructing tumors.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No