Clinical trial NCT05505279: Ventilatory Effects of THRIVE During EBUS
Official title: Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercapnia
Sedation Complication
High Flow Nasal Cannula
Keywords: High Flow Nasal Cannula
Sedation
Dead space ventilation
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2022-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inspiratory CO2 at 10 minutes (baseline)
timeFrame: at t=10 minutes
measure: Inspiratory CO2 at 25 minutes
timeFrame: at=25 minutes
measure: Inspiratory CO2 at 45 minutes
timeFrame: at t=45 minutes
measure: expiratory CO2 at 10 minutes (baseline)
timeFrame: at t=10 minutes
measure: expiratory CO2 at 25 minutes
timeFrame: at t=25 minutes
measure: expiratory CO2 at 45 minutes
timeFrame: t=45 minutes
measure: Slope of capnography at 10 minutes (baseline)
timeFrame: At t=10 minutes
measure: Slope of capnography at 25 minutes
timeFrame: At t=25 minutes
measure: Slope of capnography at 45 minutes
timeFrame: At t=45 minutes
Secondary outcomes:
measure: Respiratory rate
timeFrame: At t=10 minutes
measure: Respiratory rate
timeFrame: At t=25 minutes
measure: Respiratory rate
timeFrame: At t=45 minutes
measure: The level of HFNC dead space washout
timeFrame: At t=10 minutes
measure: The level of HFNC dead space washout
timeFrame: At t=25 minutes
measure: The level of HFNC dead space washout
timeFrame: At t=45 minutes
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
name: Jeffrey Miechels
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
name: Mark V Koning, MD, PhD
role: STUDY_CHAIR
affiliation: Dept. of Pulmonology, Rijnstate Hospital, Arnhem
name: Niels Claessens, MD, PhD
role: STUDY_DIRECTOR
References: