Using Electrical Impedance Tomography to Investigate the Relationship Between Airflow Rate During High-flow Oxygen Therapy and Pressure in Patients With Heart Failure Compared to Non-invasive Ventilation

October 16, 2024 updated by: National Taiwan University Hospital

Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).

This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.

The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.

The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Non-invasive ventilation (NIV) has been widely used in heart failure patients with supporting evidence. However, the drawbacks and contraindications associated with NIV limit its applicability in certain patients. Recently, high-flow oxygen therapy (HFOT) has gained popularity, particularly in the context of the COVID-19 pandemic, due to its documented benefits, improved patient comfort and fewer contraindications. Studies have suggested that HFOT can generate positive end-expiratory pressure (PEEP) similar to NIV, thereby increasing end-expiratory lung volume. However, the specific effects of PEEP remain unknown, as previous research only monitored the upper airway pressure. Therefore, this study aims to explore the flow-pressure relationship between HFOT and NIV in heart failure patients using electrical impedance tomography (EIT).

This prospective randomized crossover clinical trial will be conducted at a single medical center with multiple intensive care units. Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase, during which parameters including respiratory rate, heart rate, blood pressure, peripheral oxygen saturation, and oxygen concentration will be recorded. NIV will be administered in continuous positive airway pressure (CPAP) mode. Additional parameters such as tidal volume, respiratory rate, minute ventilation, leak flow, and peak inspiratory pressure will be recorded for NIV.

The study protocols for Group A will follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O. Group B will follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L. This means that each intervention will be performed in the order listed, with one intervention completed before moving on to the next.

The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities. All data will be stored for offline analysis.

The primary outcome will compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O. The secondary study aims to assess the corresponding PEEP values in NIV with CPAP under different airflow rates during HFOT.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yao-Wen Kuo
  • Phone Number: 251821 +886223123456
  • Email: kyw@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients in the intensive care unit (ICU) with PaO2/FiO2 ≤ 300, requiring Non-Invasive Ventilation (NIV) and High-Flow Oxygen Therapy (HFOT) and stable use of NIV and HFOT for at least 24 hours will be eligible for enrollment.
  • Evidence of pulmonary infiltrates on chest X-ray in patients with heart failure.
  • Alert and able to follow instructions.

Exclusion Criteria:

  • Age < 18 years.
  • Patients with a history of tracheostomy.
  • Hemodynamically unstable (defined as a mean arterial pressure persistently below 60 mmHg despite fluid resuscitation or vasopressor support).
  • Severe chronic obstructive pulmonary disease (COPD).
  • History of nasal trauma and/or nasal septal deviation or any other reason preventing the use of High-Flow Oxygen Therapy (HFOT).
  • Presence of facial wounds or any other reason preventing the use of Non-Invasive Ventilation (NIV).
  • Contraindications to Electrical Impedance Tomography (EIT) use (e.g., patients with implanted pacemakers) or inability to place EIT belt (e.g., due to wound dressings or chest drainage).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
follow the sequence of oxygen mask, HFOT 40L, HFOT 50L, HFOT 60L, oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, and CPAP 6cmH2O.
Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)
Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase. NIV will be administered in continuous positive airway pressure (CPAP) mode. The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities.
Other: Group B
follow the sequence of oxygen mask, CPAP 4cmH2O, CPAP 5cmH2O, CPAP 6cmH2O, oxygen mask, HFOT 40L, HFOT 50L, and HFOT 60L.
Device: Non-invasive ventilation (NIV) or high-flow oxygen therapy (HFOT) using electrical impedance tomography (EIT)
Participants will be randomly assigned to Groups A and B using a computerized randomization process. Each group will undergo specific protocols for 5-10 minutes per phase. NIV will be administered in continuous positive airway pressure (CPAP) mode. The participants will be positioned in a semi-recumbent position at 45 degrees, and the EIT belt will be placed around the fifth (or sixth) intercostal space for monitoring. The EIT signals will be filtered with a cut-off frequency set at 10 beats below the current heart rate. The entire procedure is estimated to take approximately 1-1.5 hours, and recalibration will only be performed in case of significant signal abnormalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT and NIV
Time Frame: approximately 1-1.5 hours
compare the difference of global end-expiratory lung impedance (ΔEELI) between HFOT with a flow rate of 40 L/min and NIV with CPAP 4 cmH2O.
approximately 1-1.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PEEP values in NIV with CPAP under different airflow rates during HFOT
Time Frame: approximately 1-1.5 hours
assess the ΔEELI corresponding PEEP values in NIV with CPAP under different airflow rates during HFOT
approximately 1-1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: MING-HANN SHIN, Division of Respiratory Therapy, Department of Integrated Diagnostic and Therapeutics, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307158DINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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