Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU (NCT04041817) | Clinical Trial Compass
CompletedNot Applicable
Pulmonary and Ventilatory Effects of Trigger Modulation in Intubated ICU
France30 participantsStarted 2019-04-03
Plain-language summary
Pressure support ventilation allows intubated ICU patients to breathe spontaneously. Among specific settings, the adjustment of the trigger value (or threshold for triggering the ventilator) has not been explored to date. The trigger threshold corresponds to the sensitivity of the ventilator to detect patient's inspiratory effort and then deliver the predefined pressure support to inflate the lungs and deliver a tidal volume. The purpose of this study is to explore the influence of trigger level on pulmonary and ventilatory physio (-patho)logical parameters in spontaneously breathing ICU patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Patient hospitalized in the Intensive Care Unit of Clermont-Ferrand's Hospital
* Patients with mechanical invasive ventilation in spontaneous ventilation with inspiratory support (intubation or tracheostomy)
* Trigger level set to minimum
* Patient under sedation compatible with spontaneous ventilation (SV) with inspiratory support (AI) and positive end-expiratory pressure (PEP) Patient calm (RASS between -2 and 0) Consent for participation or consent from patient's next of kin or inclusion according to an emergency procedure Patient benefiting from the French social security scheme
Exclusion Criteria:
* Refusal to participate in the proposed study
* Contraindication to the installation of a nasogastric tube:
* Severe disorder of uncorrected blood clotting
* Known nasosinus lesion
* Oesophageal varices recently ligated (\<48h)
* Contraindication to the use of the electro-impedancemetry technique by tomography
* Thoracic lesions
* Chest dressings
* Pace-maker / Implantable Defibrillator
* Known lesion of central respiratory centers, including patients with neurological injury
* Patients with Acute Respiratory Distress Syndrome (according to Berlin criteria)
* Patients with restrictive or obstructive pulmonary pathology
* Patients admitted post-operatively for surgery that may affect the diaphragmatic function ( thoracic or abdominal supra-mesocolic)
* Patients with abdominal distention (ileus, intra-abdominal hyperpressure…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T0 (before the first trigger step)
2
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T15 minutes (last minute of the trigger step n°1)
3
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T30 minutes (last minute of the trigger step n°2)
4
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T45 minutes (last minute of the trigger step n°3)
5
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T60 minutes (last minute of the trigger step n°4)
6
Lung volume (end expiratory lung volume, EELV) at each trigger level
Timeframe: T75 minutes (last minute of the trigger step n°5)
7
Lung volume (end expiratory lung volume, EELV) at each trigger level