CompletedNot Applicable

EAdi as a Predictor of Successful Extubation in Patients With Traumatic Cervical Spinal Cord Injury

China107 participantsStarted 2014-06-01

Plain-language summary

Esophageal recordings of diaphragm electrical activity (EAdi) made it possible to monitor respiratory drive and the subsequent phrenic nerve conduction and respiratory neuromuscular function continuously. Thus, we designed a "spontaneous breathing challenge" test to monitor the change in EAdi after a maximal inspiration. We hypothesized that the absolute change (ΔEAdi) and the percentage changes change (ΔEAdi%) in EAdi after a "spontaneous breathing challenge" predict successful extubation in traumatic CSCI patients during acute hospitalization.

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 or older
. Traumatic CSCI patients with a neurologic level of injury of C1 to C8 by the American Spinal Injury Association (ASIA) standard impairment scale grade A to D
. patients with mechanical ventilation due to acute respiratory failure and admit to ICU
. with dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in position.

Exclusion criteria

. tracheostomy before ICU admission
. withhold or withdraw life sustaining treatment due to other serious organ injury

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

extubation Success

Timeframe: up to 90 days

Trial details

NCT IDNCT04089956

SponsorSoutheast University, China

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-30

View on ClinicalTrials.gov More Traumatic Cervical Spinal Cord Injury (CSCI) trials