Ventilatory Effects of THRIVE During EBUS

Rijnstate Hospital

Status and phase: Completed; Phase 3

Conditions: Sedation Complication; Hypercapnia; High Flow Nasal Cannula

Treatments: Device: THRIVE (High Flow Nasal Cannula)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05505279

2022-2031

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

30 L - 70 L

Active Comparator group

Description:

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.

Treatment:

Device: THRIVE (High Flow Nasal Cannula)

70 L - 30 L

Active Comparator group

Description:

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.

Treatment:

Device: THRIVE (High Flow Nasal Cannula)