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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04089956
Enrollment
107
Registered
2019-09-13
Start date
2014-06-01
Completion date
2023-04-30
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Cervical Spinal Cord Injury (CSCI)

Keywords

spinal cord injury, weaning

Brief 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.

Interventions

OTHERNo interventation

A retrospective cohort Observational study with no intervention

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age 18 years or older 2. 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 3. patients with mechanical ventilation due to acute respiratory failure and admit to ICU 4. with dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in position.

Exclusion criteria

1. tracheostomy before ICU admission 2. withhold or withdraw life sustaining treatment due to other serious organ injury 3. can't complete instructional actions, 4. death occurred within 7 days after injury 5. postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively. 6. EAdi data not available

Design outcomes

Primary

MeasureTime frameDescription
extubation Successup to 90 daysdefined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay

Secondary

MeasureTime frameDescription
ventilator free daysup to 28 daysdays of nowvntilation at day 7,14,28
complicationsup to 90 dayscomplications of mechanication ventilation such as VAP and so on
mortalityup to 90 daysin-ICU and in hospital mortality
length of stayup to 90 dayslength of stay in-ICU and in hospital

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026