## Protocol Section
### Identification Module
**NCT ID:** NCT05505279

**Brief Title:** Ventilatory Effects of THRIVE During EBUS

**Official Title:** Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?

#### Organization Study ID Info
**ID:** 2022-2031
#### Organization
**Class:** OTHER
**Full Name:** Rijnstate Hospital
### Status Module
#### Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-10-05

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2022-08-17
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-10
**Study First Submit QC Date:** 2022-08-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Fisher and Paykel Healthcare

#### Lead Sponsor

**Class:** OTHER

**Name:** Rijnstate Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Hypercapnia

- Sedation Complication

- High Flow Nasal Cannula

**Keywords:**

- High Flow Nasal Cannula

- Sedation

- Dead space ventilation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** TRIPLE

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

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: THRIVE (High Flow Nasal Cannula)

**Label:** 30 L - 70 L

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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.

**Intervention Names:**

- Device: THRIVE (High Flow Nasal Cannula)

**Label:** 70 L - 30 L

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 30 L - 70 L

- 70 L - 30 L

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

**Name:** THRIVE (High Flow Nasal Cannula)

**Other Names:**

- THRIVE

- Optiflow

- High Flow Nasal Cannula

- High Flow Nasal Oxygen

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Inspiratory CO2, measured at the carinal level

**Measure:** Inspiratory CO2 at 10 minutes (baseline)

**Time Frame:** at t=10 minutes

**Description:** Inspiratory CO2, measured at the carinal level

**Measure:** Inspiratory CO2 at 25 minutes

**Time Frame:** at=25 minutes

**Description:** Inspiratory CO2, measured at the carinal level

**Measure:** Inspiratory CO2 at 45 minutes

**Time Frame:** at t=45 minutes

**Description:** Expiratory CO2, measured at the carinal level

**Measure:** expiratory CO2 at 10 minutes (baseline)

**Time Frame:** at t=10 minutes

**Description:** Expiratory CO2, measured at the carinal level

**Measure:** expiratory CO2 at 25 minutes

**Time Frame:** at t=25 minutes

**Description:** Expiratory CO2, measured at the carinal level

**Measure:** expiratory CO2 at 45 minutes

**Time Frame:** t=45 minutes

**Description:** Angle of the D-E segment (inspiratory slope)

**Measure:** Slope of capnography at 10 minutes (baseline)

**Time Frame:** At t=10 minutes

**Description:** Angle of the D-E segment (inspiratory slope)

**Measure:** Slope of capnography at 25 minutes

**Time Frame:** At t=25 minutes

**Description:** Angle of the D-E segment (inspiratory slope)

**Measure:** Slope of capnography at 45 minutes

**Time Frame:** At t=45 minutes

#### Secondary Outcomes

**Description:** Respiratory rate, measured by capnography

**Measure:** Respiratory rate

**Time Frame:** At t=10 minutes

**Description:** Respiratory rate, measured by capnography

**Measure:** Respiratory rate

**Time Frame:** At t=25 minutes

**Description:** Respiratory rate, measured by capnography

**Measure:** Respiratory rate

**Time Frame:** At t=45 minutes

**Description:** Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

**Measure:** The level of HFNC dead space washout

**Time Frame:** At t=10 minutes

**Description:** Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

**Measure:** The level of HFNC dead space washout

**Time Frame:** At t=25 minutes

**Description:** Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level.

**Measure:** The level of HFNC dead space washout

**Time Frame:** At t=45 minutes

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jmiechels@rijnstate.nl

**Name:** Jeffrey Miechels

**Phone:** 0031-88-0058888

**Role:** CONTACT

**Contact 2:**

**Email:** MVKoning@rijnstate.nl

**Name:** Mark V Koning, MD, PhD

**Phone:** 0031-88-0058888

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Arnhem

**Contacts:**

***Contact 1:***

- **Email:** jmiechels@rijnstate.nl

- **Name:** Jeffrey Miechels

- **Role:** CONTACT

***Contact 2:***

- **Email:** MVKoning@rijnstate.nl

- **Name:** Mark V Koning, MD, PhD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Niels Claessens, MD, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Netherlands

**Facility:** Rijnstate Hospital

**Status:** RECRUITING

**Zip:** 6815 AD

#### Overall Officials

**Official 1:**

**Affiliation:** Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

**Name:** Jeffrey Miechels

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem

**Name:** Mark V Koning, MD, PhD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Dept. of Pulmonology, Rijnstate Hospital, Arnhem

**Name:** Niels Claessens, MD, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Upon reasonable request and within the limits of the law on patient data distribution.

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M9986

- Name: Hypercapnia

- Relevance: HIGH

- As Found: Hypercapnia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006935

- Term: Hypercapnia

### Intervention Browse Module - Ancestors

- ID: D000005731

- Term: Ganglionic Stimulants

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018722

- Term: Nicotinic Agonists

- ID: D000018679

- Term: Cholinergic Agonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: HIGH

- As Found: >50

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M20796

- Name: Nicotinic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009538

- Term: Nicotine

### Misc Info Module

- Version Holder: 2024-05-24
