CompletedNot Applicable

New Setting of Neurally Adjusted Ventilatory Assist During Mask Noninvasive Ventilation

14 participantsStarted 2013-03

Plain-language summary

Non invasive ventilation (NIV) is generally delivered by pneumatically triggered and cycled-off Pressure Support (PSP) through a facial mask. Compared to PSP, Neurally Adjusted Ventilatory Assist (NAVA), which is the only ventilatory mode using a non-pneumatic signal, i.e., diaphragm electrical activity (EAdi), to trigger and drive ventilator assistance, improves patient-ventilator interaction. A specific setting to generate neurally controlled Pressure Support (PSN) was recently proposed for delivering NIV by helmet. The investigators here compare PSN with PSP and NAVA during NIV by facial mask, with respect to arterial blood gases (ABGs), patient comfort, and patient-ventilator interaction and synchrony. Three 30-minute trials of NIV were randomly delivered to 14 patients immediately after extubation to prevent post-extubation respiratory failure: 1) PSP, with an inspiratory support ≥8 cmH2O; 2) NAVA, adjusting the NAVA level to achieve a comparable peak EAdi (EAdipeak) as during PSP; 3) PSN, setting the NAVA level at 15 cmH2O/mcV with an upper airway pressure (Paw) limit such to obtain the same overall Paw applied during PSP. We assessed EAdipeak, ABGs, peak inspiratory flow (PIF), time to reach PIF (PIFtime), pressure-time product of the first 300 (PTP300-index) and 500 (PTP500-index) milliseconds after initiation of patient effort, patient comfort, inspiratory trigger delay (DelayTR-insp), and the rate of asynchrony, as assessed by the Asynchrony Index (AI%).

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.

The investigators considered eligible: * any patient ≥18 years admitted in ICU undergoing invasive mechanical ventilation for at least 48 hours with a Glasgow Coma Scale (GCS) of 11 (i.e.; spontaneous eyes opening, obeys to command, no verbal response because of the endotracheal tube in place), * no infusion of midazolam and propofol in the previous 24 and 4 hours, respectively * ready for extubation with indication, prior to extubation, to receive prophylactic NIV to prevent post-extubation respiratory failure. Patients were excluded in case of * need for analgesic or sedative drugs, * recent cervical spine injury, * obstructive sleep apnoea syndrome, * pregnancy, * contraindications to placement of a nasal-gastric feeding tube, * inclusion in other research protocol * lack of consent.

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

Rate of ventilator cycling (RRmec)

Timeframe: 30 minutes within the trial

Trial details

NCT IDNCT03041402

SponsorSoutheast University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-09

View on ClinicalTrials.gov More Acute Respiratory Failure trials