Feasibility of Reducing Respiratory Drive Using the Through-flow System

NCT05642832 | Recruiting

• 1 other identifier: 21-5534
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation can lead to diaphragm and lung injury. During mechanical ventilation, the diaphragm could be completely rested or it could be overworked, either of which may cause diaphragm injury. Mechanical stress and strain applied by mechanical ventilation or by the patient's own respiratory muscles can also cause injury to the lungs. Diaphragm and lung injury are associated with increased morbidity and mortality. Throughflow is a novel system that can reduce dead space without the need to increase the tidal ventilation, reducing the ventilatory demands and respiratory drive.

Conditions

Respiratory Insufficiency; Diaphragm Injury; Lung Injury

Outcome Measures

Primary Outcomes (3)

• Esophageal pressure swing (respiratory effort)

  Changes in esophageal pressure swing from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

  24 hours

• Dynamic driving transpulmonary pressure (lung-distending pressure)

  Changes in the dynamic driving transpulmonary pressure from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

  24 hours

• Oxygenation (PaO2/FiO2 ratio)

  Changes in PaO2/FiO2 from baseline to protocol completion will be described using central tendency and dispersion measurements (median and 25%-75% interquartile range) for each variable at each time point of the protocol

  24 hours

Secondary Outcomes (1)

• Rate of serious adverse events

  24 hours

Study Arms (1)

Throughflow

EXPERIMENTAL

Throughflow is a novel system that reduces anatomical dead space by providing a constant flow of fresh gas (i.e., gas that is free of CO2) during inspiration in patients receiving invasive mechanical ventilation. By clearing the CO2 that normally remains in the upper airway after exhalation (anatomical dead space), TF can dramatically reduce anatomical dead space without the need to increase the delivered VT, making it a safe strategy in terms of lung protection. This reduction in dead space reduces the ventilatory demands of the patients, reducing respiratory drive.

Device: Throughflow titration phase

Interventions

Throughflow titration phase DEVICE

Ventilation will be applied in the TF mode with TF set to 0 LPM for 10 minutes. Patients will receive assist through the NAVA line of the tri-piece (NAVA set to similar settings as Servo period, \~60-80 LPM flow). Ventilation with Throughflow will be started at a TF flow of 5 LPM, and the NAVA flow will be reduced by 5 LPM. After 10 minutes measurements will be collected. If Edi is greater than or equal to 4 µV, TF flow will be increased to 10 LPM and NAVA flow will be adjusted to keep total flow constant. Measurements will be collected again after 10 minutes. TF flow will be increased in steps of 5 LPM and measurements collected every 10 minutes until Edi is below 3 µV or TF flow reaches the total flow observed during the NAVA period. After either the Edi target has been met or TF flow has reached the total flow, ventilation with TF will be reduced in steps of 5 LPM every 10 minutes (the reverse of the above), while NAVA flow is accordingly adjusted to keep total flow constant.

Throughflow

Eligibility Criteria

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

You may qualify if:

• PaO2/FiO2 less than or equal to 300 at time of screening
• Oral endotracheal intubation with ETT 7.5 or 8.0 and on invasive mechanical ventilation
• Bilateral airspace opacities on chest radiograph or chest CT scan

You may not qualify if:

• Contraindication to esophageal catheterization (upper gastrointestinal tract surgery within preceding 6 weeks, bleeding esophageal/gastric varices)
• Intubation for traumatic brain injury or stroke
• Intracranial hypertension (suspected or diagnosed by medical team)
• Anticipated liberation from mechanical ventilation within 24 hours

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Unity Health Toronto: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lorenzo Del Sorbo

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu ( Cindy) Jin

CONTACT

4163404800; rongyu.jin@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: December 8, 2022
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)