Ventilatory Effects of THRIVE During EBUS

NCT05505279 | Completed Phase 3

• 1 other identifier: 2022-2031
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercapnia; Sedation Complication; High Flow Nasal Cannula

Keywords

High Flow Nasal Cannula; Sedation; Dead space ventilation

Outcome Measures

Primary Outcomes (9)

• Inspiratory CO2 at 10 minutes (baseline)

  Inspiratory CO2, measured at the carinal level

  at t=10 minutes

• Inspiratory CO2 at 25 minutes

  Inspiratory CO2, measured at the carinal level

  at=25 minutes

• Inspiratory CO2 at 45 minutes

  Inspiratory CO2, measured at the carinal level

  at t=45 minutes

• expiratory CO2 at 10 minutes (baseline)

  Expiratory CO2, measured at the carinal level

  at t=10 minutes

• expiratory CO2 at 25 minutes

  Expiratory CO2, measured at the carinal level

  at t=25 minutes

• expiratory CO2 at 45 minutes

  Expiratory CO2, measured at the carinal level

  t=45 minutes

• Slope of capnography at 10 minutes (baseline)

  Angle of the D-E segment (inspiratory slope)

  At t=10 minutes

• Slope of capnography at 25 minutes

  Angle of the D-E segment (inspiratory slope)

  At t=25 minutes

• Slope of capnography at 45 minutes

  Angle of the D-E segment (inspiratory slope)

  At t=45 minutes

Secondary Outcomes (6)

• Respiratory rate

  At t=10 minutes

• Respiratory rate

  At t=25 minutes

• Respiratory rate

  At t=45 minutes

• The level of HFNC dead space washout

  At t=10 minutes

• The level of HFNC dead space washout

  At t=25 minutes

Study Arms (2)

30 L - 70 L

ACTIVE COMPARATOR

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.

Device: THRIVE (High Flow Nasal Cannula)

70 L - 30 L

ACTIVE COMPARATOR

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.

Device: THRIVE (High Flow Nasal Cannula)

Interventions

THRIVE (High Flow Nasal Cannula) DEVICE

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

Also known as: THRIVE, Optiflow, High Flow Nasal Cannula, High Flow Nasal Oxygen

30 L - 70 L; 70 L - 30 L

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Hypercapnia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jeffrey Miechels

  Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

  PRINCIPAL INVESTIGATOR

• Mark V Koning, MD, PhD

  Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

  STUDY CHAIR

• Niels Claessens, MD, PhD

  Dept. of Pulmonology, Rijnstate Hospital, Arnhem

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 17, 2022
• Study Start: October 5, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)