Mechanical Ventilation ComplicationEADITRAPNCT05574829
Neural Pressure Support and Non-invasive Estimation of Transpulmonary Pressure in Spontaneous Ventilation Modes
An observational study of Mechanical Ventilation Complication, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
The transition from controlled mechanical ventilation to assisted ventilation is one of the most complex and compromised phases of the ventilatory management during mechanical ventilation, affected by factors such as: Asynchronies, due to patient-respirator dis-synchrony in ins- and expiratory neural and mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Esophageal manometry and monitoring of electrical activity of the diaphragm
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2022to 31 Mar 2023
- 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: Adult patients under assisted mechanical ventilation with spontaneous breathing and adequate respiratory drive.
Who may be able to join
- Age > 18 years
- Mechanically assisted ventilation
- Patients with a nasogastric catheter
- Obtained informed consent
- Clinical stability, defined as:
- Low ventilatory support requirement: FiO2 (Fraction of inspired oxygen) ≤ 0.5; PEEP (positive end-expiratory pressure) ≤ 10 cmH2O (up to 12 cmH2O for patients with a body mass index ≥ 30 kg/m2).
- Haemodynamic stability: a)low vasopressor requirement: Noradrenaline ≤ 0.2 microg/kg/min; b)Mean blood pressure ≥ 60 mmHg; c)No new arrhythmias.
Who cannot join
- Presence of Contraindications for the insertion of a nasogastric tube: oesophageal pathology. Coagulopathy, bleeding diathesis
- Clinical instability
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Fernando Suarez Sipmann, MD, +34 665052460, fsuarezsipmann@gmail.com
Marta Sanchez Galingo, MD, +34 675203249, martasangal_6@hotmail.com
About this study
Official title: Assessment of Neural Pressure Support Assisted Ventilation and Non-invasive Estimation of Transpulmonary Pressure in Spontaneous Ventilation Modes
The transition from controlled mechanical ventilation to assisted ventilation is one of the most complex and compromised phases of the ventilatory management during mechanical ventilation, affected by factors such as:
- Asynchronies, due to patient-respirator dis-synchrony in ins- and expiratory neural and mechanical times, as well as inadequate levels of assistance.
- Risks of self-induced lung injury resulting from uncontrolled increases in transpulmonary pressure when high inspiratory efforts are combined with inappropriate levels of inspiratory pressure assistance.
Read more
Current monitoring of assisted ventilation is complex and not well resolved by most conventional ventilators. Asynchronies are difficult to monitor with the pressure or flow/time curves present in conventional ventilators requiring an advanced level of expertise. Measurements of the patient's muscular effort and therefore of transpulmonary pressure, requires the use of esophageal manometry with cumbersome handling and interpretation.
NAVA (Neurally Adjusted Ventilatory Assist) is a ventilator mode that uses electrical activity of the diaphragm (EAdi), monitored via a modified nasogastric feeding catheter, to control and assist the respiratory cycle by the ventilator. Recently, a "hybrid" mode between the conventional pressure support assisted mode (PSV) and NAVA called Neural-Pressure Support Ventilation (N-PSV) has been developed. This mode uses a neural trigger based on the EAdi to match the patient's and ventilator's in- and expiratory time, but unlike NAVA, assisting in the same way as in pressure support. In addition the EAdi allows to assess the extent to which the patient's muscle strength contributes to the patient-ventilator breath (PVBC), and it has recently been suggested that on the basis of PVBC it may also be possible to directly estimate the patient's transpulmonary pressure (PL).
Hypothesis:
- EAdi allows direct estimation of PL during the assisted ventilation phase without the need of an oesophageal pressure balloon.
- N-PSV can provide advantages over PSV by better matching ventilator and patient respiratory cycle times, thus reducing the risk of asynchronies.
Read the detailed description
Consenting participants will be simultaneously monitored with a 8French EAdi catheter (to measure the electrical activity of the diaphragm) and a 15French nasogastric catheter with an oesophageal balloon to measure oesophageal manometry during the 120 min of the total study period.
After confirming correct positioning and measurement of both catheters participants will be submitted to the following protocol:
Baseline ventilation in pressure support ventilation during 30 min Baseline ventilation in neural-pressure support ventilation during 30 min Under-assistance in neural pressure support ventilation reducing the baseline level of pressure support by 50% (with a minimum of 5 cmH2O) during 30 min Over-assistance in neural pressure support ventilation by increasing the baseline level of pressure by 50% during 30 min.
The sequence of the last two steps will be randomly determined. After completing the protocol the EAdi catheter will be removed.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Esophageal manometry and monitoring of electrical activity of the diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal manometry and monitoring of electrical activity of the diaphragmDevice
Esophageal manometry and monitoring of electrical activity of the diaphragm
| Study group | Role | What they receive |
|---|---|---|
| Patients under pressure support ventilation | Patients under assisted mechanical ventilation monitored with esophageal manometry and electrical activity of the diaphragm Receives: Device: Esophageal manometry and monitoring of electrical activity of the diaphragm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of asynchronies
Asynchrony index
Measured: 60 minutes
Estimation of transpulmonary pressure
Evaluation of a new method for measuring transpulmonary pressure based on the electrical activity of the diaphragm
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start20 May 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Maquet Critical Care AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574829
- Sponsor's protocol ID
- EADITRAP
- Acronym
- EADITRAP
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neural Pressure Support Assisted Ventilation and Non-invasive Estimation of Transpulmonary Pressure in Spontaneous Ventilation Modes
- ClinicalTrials.gov ID
- NCT05574829
- Acronym / sponsor ID
- EADITRAP / EADITRAP
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Maquet Critical Care AB
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 12 Oct 2022 (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.
The transition from controlled mechanical ventilation to assisted ventilation is one of the most complex and compromised phases of the ventilatory management during mechanical ventilation, affected by factors such as:
- Asynchronies, due to patient-respirator dis-synchrony in ins- and expiratory neural and mechanical times, as well as inadequate levels of assistance.
- Risks of self-induced lung injury resulting from uncontrolled increases in transpulmonary pressure when high inspiratory efforts are combined with inappropriate levels of inspiratory pressure assistance.
Current monitoring of assisted ventilation is complex and not well resolved by most conventional ventilators. Asynchronies are difficult to monitor with the pressure or flow/time curves present in conventional ventilators requiring an advanced level of expertise. Measurements of the patient's muscular effort and therefore of transpulmonary pressure, requires the use of esophageal manometry with cumbersome handling and interpretation.
NAVA (Neurally Adjusted Ventilatory Assist) is a ventilator mode that uses electrical activity of the diaphragm (EAdi), monitored via a modified nasogastric feeding catheter, to control and assist the respiratory cycle by the ventilator. Recently, a "hybrid" mode between the conventional pressure support assisted mode (PSV) and NAVA called Neural-Pressure Support Ventilation (N-PSV) has been developed. This mode uses a neural trigger based on the EAdi to match the patient's and ventilator's in- and expiratory time, but unlike NAVA, assisting in the same way as in pressure support. In addition the EAdi allows to assess the extent to which the patient's muscle strength contributes to the patient-ventilator breath (PVBC), and it has recently been suggested that on the basis of PVBC it may also be possible to directly estimate the patient's transpulmonary pressure (PL).
Hypothesis:
- EAdi allows direct estimation of PL during the assisted ventilation phase without the need of an oesophageal pressure balloon.
- N-PSV can provide advantages over PSV by better matching ventilator and patient respiratory cycle times, thus reducing the risk of asynchronies.
Detailed description
Consenting participants will be simultaneously monitored with a 8French EAdi catheter (to measure the electrical activity of the diaphragm) and a 15French nasogastric catheter with an oesophageal balloon to measure oesophageal manometry during the 120 min of the total study period.
After confirming correct positioning and measurement of both catheters participants will be submitted to the following protocol:
Baseline ventilation in pressure support ventilation during 30 min Baseline ventilation in neural-pressure support ventilation during 30 min Under-assistance in neural pressure support ventilation reducing the baseline level of pressure support by 50% (with a minimum of 5 cmH2O) during 30 min Over-assistance in neural pressure support ventilation by increasing the baseline level of pressure by 50% during 30 min.
The sequence of the last two steps will be randomly determined. After completing the protocol the EAdi catheter will be removed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under pressure support ventilation | – | Device: Esophageal manometry and monitoring of electrical activity of the diaphragmPatients under assisted mechanical ventilation monitored with esophageal manometry and electrical activity of the diaphragm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients under assisted mechanical ventilation with spontaneous breathing and adequate respiratory drive.
Key inclusion criteria (7 listed)
- Age > 18 years
- Mechanically assisted ventilation
- Patients with a nasogastric catheter
- Obtained informed consent
- Clinical stability, defined as:
Key exclusion criteria (2 listed)
- Presence of Contraindications for the insertion of a nasogastric tube: oesophageal pathology. Coagulopathy, bleeding diathesis
- Clinical instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal manometry and monitoring of electrical activity of the diaphragmEsophageal manometry and monitoring of electrical activity of the diaphragm | Device | Patients under pressure support ventilation |
Primary outcome
Number of asynchronies
Time frame: 60 minutes
Asynchrony index
Estimation of transpulmonary pressure
Time frame: 90 minutes
Evaluation of a new method for measuring transpulmonary pressure based on the electrical activity of the diaphragm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation Complication
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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.
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 Mechanical Ventilation Complication, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Suarez Sipmann, MD (+34 665052460, fsuarezsipmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of asynchronies (time frame: 60 minutes). 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 13 Oct 2022.