ARDS, HumanNCT04442815
EIT in Patient Ventilator Asynchrony
An observational study of ARDS, Human, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS), various types of patient ventilator asynchrony may lead to injury of the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Dec 2019to 31 May 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderate to severe ARDS patients
Who may be able to join
- Clinical diagnosis of moderate to severe ARDS
Who cannot join
- Severe chronic obstructive pulmonary diseases
- Proved barotrauma (including pneumothorax or pneumomediastinum etc.);
- Pregnancy
- Diseases characterized with increased intracranial pressure
- Patients or family who refused the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Patient Ventilator Asynchrony Using Electrical Impedance Tomography (EIT) in Patients With Acute Respiratory Failure
Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS), various types of patient ventilator asynchrony may lead to injury of the lung. For example, double cycling may lead to high tidal volume and pendelluft may result in transient overstretch of dependent lung region. In this project, the investigators will record and analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the regional distribution of lung gas and determined their harmful effect via concomitant recording of EIT and transpulmonary pressure. The results may influence our ventilator management of ARDS patients.
Read the detailed description
Patients and Methods:
Admitted ventilated patients who are greater than 18 years old and fulfilled the Berlin's diagnostic criteria of moderate to severe ARDS will be selected to enter our study. The exclusion criteria include (1) patients with metallic materials in the body (including wire, pin or implanted electrical devices etc.); (2) patients with cutaneous diseases which prohibited the application of electrode leads to attached the body; (3) severe chronic obstructive pulmonary diseases; (4) hemodynamically unstable; (5) proved barotrauma (including pneumothorax or pneumomediastinum etc.); (6) pregnancy; (7) diseases characterized with increased intracranial pressure; (8) patients or family who refused the informed consent. All patients who fulfilled the diagnosis of ARDS will receive standard care of low tidal volume ventilator therapy. The tidal volume 6 ml/Kg will be used. The investigators expect to enroll at least 20 analyzable cases. Sedation and paralysis are usually used in moderate to severe ARDS patients and daily interruption of sedation and paralysis is a standard practice. The investigators will perform recording during daily interruption of sedation and paralysis, up to 60 minutes period will be recorded during the interruption period. Recording will be done at least once for registered case and could be repeated in case of unsatisfactory signals.
Instrumentation In all patients, air flow will be measured using a pneumotachograph (Hamilton AG, or Hans Rudolf) connected to a differential pressure transducer (MP 45, Validyne Corp., Northridge, CA). The flow sensor will be placed between the endotracheal tube and the Y-piece of the ventilator. Tidal volume will be obtained by integrating the flow signal. Airway pressure and esophageal pressure will be measured using differential pressure transducers (P300D, Validyne Corp., Northridge, CA.). An appropriate esophageal pressure signal will be confirmed according to the standard guideline[27]. All signals are sampled and digitalized at 200 Hz and data are stored in a data acquisition system (MP150, Acqknowledgement, Biopac, Goleta, CA).
Measurements:
Electrical impedance tomography:
The investigators use a commercial EIT monitor (PulmoVista 500, Drager Medical GmbH, Lubeck, Germany). An electrode belt with 16 equally spaced electrodes will be placed around the patient's thorax at the 4th to 5th intercostal space. Impedance data will be acquired by applying adjacent alternate current injection (50 KHz) and measuring the voltage difference between the adjacent leads and a finite element method-based, linearized Newton-Raphson reconstruction algorithm is used to construct the impedance data. The PulmoVista 500 monitor displays functional EIT images, i.e. relative impedance changes including tidal ventilation and end-expiratory lung impedance (EELI) changes. During the study phases, EIT data will be registered at 20-40 Hz and low-pass filtered (35 per minute) and stored for offline analysis.
The individual impedance recording (10 minutes per segment) will be linked into a single file and impedance calculation will thus be done off-line. The investigators will subdivide the impedance recordings into ventral to dorsal parts. The investigators define the presence of pendelluft as the presence of opposite impedance change (△Z) between dependent and independent zones during a breathing effort. The breath could occur in inspiration phase, expiratory phase or in transition. Estimation of volume of pendelluft will be determined by the integrated volume and corresponding impedance change.
Respiratory mechanics:
The investigators will record the peak and plateau airway pressure, total PEEP, flow and the esophageal pressure. Transpulmonary pressure (PL) will be calculated as the difference between Paw and Pes calculate the transpulmonary pressure.
Study protocol The investigators target at moderate to severe ARDS patients who are already under deep sedation with neuromuscular blockade. As daily interruption of sedatives and muscle relaxant are routinely performed in our ICU, we will record the respiratory mechanics and EIT data for about one hour which should include both controlled and spontaneous breathing period.
- Conditions
- ARDS, Human
- Keywords
- ARDS, patient-ventilator interaction, EIT
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient ventilator asynchrony
Various types of patient ventilator asynchrony
Measured: up to 1 hour following interruption of muscle relaxant
Regional ventilation distribution by EIT
Regional ventilation distribution by EIT in various types of patient ventilator asynchrony
Measured: up to 1 hour following interruption of muscle relaxant
Secondary outcomes (1)
hospitalization day and final outcome
duration of hospitalization and hospital mortality
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start13 Dec 2019
- Primary completion31 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Wen Chen, National Cheng-Kung University Hospital
- Investigators
- Chang-Wen Chen, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442815
- Sponsor's protocol ID
- EIT and ARF
- Status last verified
- Dec 2022
- First submitted
- 18 Jun 2020
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: IPD may be shared once the data is published
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Patient Ventilator Asynchrony Using Electrical Impedance Tomography (EIT) in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04442815
- Acronym / sponsor ID
- EIT and ARF
- Conditions
- ARDS, Human
- Keywords
- ARDS, patient-ventilator interaction, EIT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient-ventilator asynchrony is an important clinical issue in mechanically ventilated patients. For patients with moderate to severe acute respiratory distress syndrome (ARDS), various types of patient ventilator asynchrony may lead to injury of the lung. For example, double cycling may lead to high tidal volume and pendelluft may result in transient overstretch of dependent lung region. In this project, the investigators will record and analyze various types of patient-ventilator asynchrony in ARDS patients and analyze the regional distribution of lung gas and determined their harmful effect via concomitant recording of EIT and transpulmonary pressure. The results may influence our ventilator management of ARDS patients.
Detailed description
Patients and Methods:
Admitted ventilated patients who are greater than 18 years old and fulfilled the Berlin's diagnostic criteria of moderate to severe ARDS will be selected to enter our study. The exclusion criteria include (1) patients with metallic materials in the body (including wire, pin or implanted electrical devices etc.); (2) patients with cutaneous diseases which prohibited the application of electrode leads to attached the body; (3) severe chronic obstructive pulmonary diseases; (4) hemodynamically unstable; (5) proved barotrauma (including pneumothorax or pneumomediastinum etc.); (6) pregnancy; (7) diseases characterized with increased intracranial pressure; (8) patients or family who refused the informed consent. All patients who fulfilled the diagnosis of ARDS will receive standard care of low tidal volume ventilator therapy. The tidal volume 6 ml/Kg will be used. The investigators expect to enroll at least 20 analyzable cases. Sedation and paralysis are usually used in moderate to severe ARDS patients and daily interruption of sedation and paralysis is a standard practice. The investigators will perform recording during daily interruption of sedation and paralysis, up to 60 minutes period will be recorded during the interruption period. Recording will be done at least once for registered case and could be repeated in case of unsatisfactory signals.
Instrumentation In all patients, air flow will be measured using a pneumotachograph (Hamilton AG, or Hans Rudolf) connected to a differential pressure transducer (MP 45, Validyne Corp., Northridge, CA). The flow sensor will be placed between the endotracheal tube and the Y-piece of the ventilator. Tidal volume will be obtained by integrating the flow signal. Airway pressure and esophageal pressure will be measured using differential pressure transducers (P300D, Validyne Corp., Northridge, CA.). An appropriate esophageal pressure signal will be confirmed according to the standard guideline[27]. All signals are sampled and digitalized at 200 Hz and data are stored in a data acquisition system (MP150, Acqknowledgement, Biopac, Goleta, CA).
Measurements:
Electrical impedance tomography:
The investigators use a commercial EIT monitor (PulmoVista 500, Drager Medical GmbH, Lubeck, Germany). An electrode belt with 16 equally spaced electrodes will be placed around the patient's thorax at the 4th to 5th intercostal space. Impedance data will be acquired by applying adjacent alternate current injection (50 KHz) and measuring the voltage difference between the adjacent leads and a finite element method-based, linearized Newton-Raphson reconstruction algorithm is used to construct the impedance data. The PulmoVista 500 monitor displays functional EIT images, i.e. relative impedance changes including tidal ventilation and end-expiratory lung impedance (EELI) changes. During the study phases, EIT data will be registered at 20-40 Hz and low-pass filtered (35 per minute) and stored for offline analysis.
The individual impedance recording (10 minutes per segment) will be linked into a single file and impedance calculation will thus be done off-line. The investigators will subdivide the impedance recordings into ventral to dorsal parts. The investigators define the presence of pendelluft as the presence of opposite impedance change (△Z) between dependent and independent zones during a breathing effort. The breath could occur in inspiration phase, expiratory phase or in transition. Estimation of volume of pendelluft will be determined by the integrated volume and corresponding impedance change.
Respiratory mechanics:
The investigators will record the peak and plateau airway pressure, total PEEP, flow and the esophageal pressure. Transpulmonary pressure (PL) will be calculated as the difference between Paw and Pes calculate the transpulmonary pressure.
Study protocol The investigators target at moderate to severe ARDS patients who are already under deep sedation with neuromuscular blockade. As daily interruption of sedatives and muscle relaxant are routinely performed in our ICU, we will record the respiratory mechanics and EIT data for about one hour which should include both controlled and spontaneous breathing period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe ARDS patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of moderate to severe ARDS
Key exclusion criteria (5 listed)
- Severe chronic obstructive pulmonary diseases
- Proved barotrauma (including pneumothorax or pneumomediastinum etc.);
- Pregnancy
- Diseases characterized with increased intracranial pressure
- Patients or family who refused the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient ventilator asynchrony
Time frame: up to 1 hour following interruption of muscle relaxant
Various types of patient ventilator asynchrony
Regional ventilation distribution by EIT
Time frame: up to 1 hour following interruption of muscle relaxant
Regional ventilation distribution by EIT in various types of patient ventilator asynchrony
1 secondary outcome
hospitalization day and final outcome
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Undecided. IPD may be shared once the data is published
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Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Wen Chen, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient ventilator asynchrony (time frame: up to 1 hour following interruption of muscle relaxant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.