Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation (VIREM)

This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.

Study Overview

• Status: Recruiting
• Conditions: Respiration, Artificial; Respiratory Muscles; Respiratory Function Tests
• Intervention / Treatment: Device: Placement of nasogastric balloon

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vertongen; Phone Number: +323 821 44 04; Email: icu-research@uza.be
• Study Contact Backup: Name: Marquez; Phone Number: +323 821 36 35; Email: inzo@uza.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospital Leuven (UZL)
    • Contact: Van Maercke; Email: francesca.vanmaercke@uzleuven.be
    • Principal Investigator: Greet Hermans, M.D., Ph.D.
    • Sub-Investigator: Lars Desmet, M.D.
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital (UZA)
      • Contact: Vertongen; Phone Number: +323 821 44 04; Email: icu-research@uza.be
      • Sub-Investigator: Tom Schepens, M.D., Ph.D.
      • Principal Investigator: Philippe G Jorens, M.D., Ph.D.
      • Sub-Investigator: Gregory R De Meyer, M.D.
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children (SickKids)
      • Contact: Ta; Email: eva.ta@sickkids.ca
      • Principal Investigator: Gail Annich, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age > 28 days
• weight > 3kg
• requiring invasive mechanical ventilation
• anticipated length of ventilation > 48h

Exclusion Criteria:

• refusal of consent
• mechanical ventilation ≤ 2 weeks before inclusion
• known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
• contra-indication to the placement of a naso-gastric esophageal balloon catheter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Overall group; Placement of a nasogastric balloon

Device: Placement of nasogastric balloon; A nasogastric balloon catheter will be inserted after inclusion. This will be a NutriVent (Sidam S.R.L., Mirandola, Italy) for patients >40kg, and a SmartCath Esophageal pressure catheter (Vyaire/Carefusion) for patients <40kg. This placement is similar to a standard nasogastric tube placement, which is a common procedure in an ICU. Potential minor side effects include a nosebleed, sore throat and erosion of the nose where the tube is anchored. All patients will receive this intervention. When the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal esophageal pressure swing (∆Pes) - D1	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D2	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D3	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D4	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D5	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D6	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D7	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation
Tidal esophageal pressure swing (∆Pes) - D8	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.	∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transpulmonary driving pressure (ΔPL) - D1	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D2	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D3	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D4	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 4 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D5	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 5 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D6	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 6 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D7	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D8	∆PL is calculated as change in airway pressure minus change in esophageal pressure	∆PL (average over 1 minute recording) at day 8 of mechanical ventilation
Occlusion pressure (P0.1) - D1	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
Occlusion pressure (P0.1) - D2	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
Occlusion pressure (P0.1) - D3	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
Occlusion pressure (P0.1) - D4	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
Occlusion pressure (P0.1) - D5	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
Occlusion pressure (P0.1) - D6	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
Occlusion pressure (P0.1) - D7	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
Occlusion pressure (P0.1) - D8	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D1	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 1 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D2	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 2 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D3	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 3 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D4	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 4 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D5	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 5 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D6	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 6 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D7	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 7 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D8	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 8 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D1	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 1 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D2	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 2 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D3	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 3 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D4	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 4 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D5	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 5 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D6	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 6 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D7	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 7 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D8	DTF is calculated as (Thickness at end-inspiration [DTei] - Thickness at end-expiration [DTee])/Thickness at end-expiration [DTee] × 100. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTF (average of 3 breaths) at day 8 of mechanical ventilation
Duration of mechanical ventilation	Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)	From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months
Maximal inspiratory pressure (MIP) - D1	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 1 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D2	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 2 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D3	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 3 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D4	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 4 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D5	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 5 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D6	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 6 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D7	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 7 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D8	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 8 of mechanical ventilation
Need for tracheal reintubation after tracheal extubation		From date of inclusion until the date of reintubation or date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months.
Lung ultrasound scores (LUSS) - D1	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 1 of mechanical ventilation
Lung ultrasound scores (LUSS) - D2	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 2 of mechanical ventilation
Lung ultrasound scores (LUSS) - D3	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 3 of mechanical ventilation
Lung ultrasound scores (LUSS) - D4	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 4 of mechanical ventilation
Lung ultrasound scores (LUSS) - D5	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 5 of mechanical ventilation
Lung ultrasound scores (LUSS) - D6	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 6 of mechanical ventilation
Lung ultrasound scores (LUSS) - D7	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 7 of mechanical ventilation
Lung ultrasound scores (LUSS) - D8	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 8 of mechanical ventilation
ICU length of stay	Duration to live discharge from the ICU	From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
ICU mortality		From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Hospital length of stay	Duration to live discharge from hospital	From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Duration to decease	Cumulative time to death counting from the day of intubation	From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Hospital mortality		From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Presence of clinical signs of muscle weakness at ICU discharge		From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Presence of clinical signs of muscle weakness at hospital discharge		From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
ICU readmission rate within 48 hours		From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Inspiratory muscle pressure (Pmus) - D1	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 1 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D2	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 2 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D3	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 3 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D4	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 4 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D5	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 5 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D6	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 6 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D7	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 7 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D8	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 8 of mechanical ventilation
Occlusion pressure (∆Pocc) - D1	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 1 of mechanical ventilation
Occlusion pressure (∆Pocc) - D2	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 2 of mechanical ventilation
Occlusion pressure (∆Pocc) - D3	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 3 of mechanical ventilation
Occlusion pressure (∆Pocc) - D4	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 4 of mechanical ventilation
Occlusion pressure (∆Pocc) - D5	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 5 of mechanical ventilation
Occlusion pressure (∆Pocc) - D6	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 6 of mechanical ventilation
Occlusion pressure (∆Pocc) - D7	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 7 of mechanical ventilation
Occlusion pressure (∆Pocc) - D8	Measured at least once daily for the first 8 days of mechanical ventilation	∆Pocc at day 8 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D1	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 1 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D2	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 2 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D3	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 3 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D4	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 4 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D5	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 5 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D6	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 6 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D7	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 7 of mechanical ventilation
Esophageal pressure-time product (PTPes) - D8	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.	PTPes at day 8 of mechanical ventilation
Dead space ventilation (VD) - D1	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 1 of mechanical ventilation
Dead space ventilation (VD) - D2	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 2 of mechanical ventilation
Dead space ventilation (VD) - D3	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 3 of mechanical ventilation
Dead space ventilation (VD) - D4	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 4 of mechanical ventilation
Dead space ventilation (VD) - D5	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 5 of mechanical ventilation
Dead space ventilation (VD) - D6	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 6 of mechanical ventilation
Dead space ventilation (VD) - D7	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 7 of mechanical ventilation
Dead space ventilation (VD) - D8	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 8 of mechanical ventilation

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: The Hospital for Sick Children; Universitaire Ziekenhuizen KU Leuven; KU Leuven; University of Toronto; Universiteit Antwerpen; Research Foundation Flanders
• Investigators: Study Director: Tom Schepens, M.D., Ph.D., PICU staff member

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: EDGE1712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes