Clinical Trials Directory

Trials / Completed

CompletedNCT04089956

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

Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury

Status
Completed
Phase
Study type
Observational
Enrollment
107 (actual)
Sponsor
Southeast University, China · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

A retrospective cohort study enrolled adult traumatic CSCI patients who underwent mechanical ventilation and admitted to the intensive care unit (ICU) of Zhongda hospital form June 2014 to July 2018. The following inclusion criteria were used: 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-D patients with mechanical ventilation due to acute respiratory failure and admite to ICU, dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in postion. CSCI was defined as radiologically-confirmed injury to the cervical spinal column, combined with clinical signs and symptoms consistent with CSCI at that level. The exclusion criteria were: tracheostomy at time of addmition to ICU, withhold or withdraw life sustaining treatment due to other serious organ injury, can't complete instructional actions, death occurred within 7 days after injury, or postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively. Extubation or tracheostomy was decided by the physician in charge according to the local protocol of weaning.

Conditions

Interventions

TypeNameDescription
OTHERNo interventationA retrospective cohort Observational study with no intervention

Timeline

Start date
2014-06-01
Primary completion
2022-05-30
Completion
2023-04-30
First posted
2019-09-13
Last updated
2023-06-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04089956. Inclusion in this directory is not an endorsement.