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

S

Southeast University, China

Status

Completed

Conditions

Traumatic Cervical Spinal Cord Injury (CSCI)

Treatments

Other: No interventation

Study type

Observational

Funder types

Other

Identifiers

NCT04089956
20190911

Details and patient eligibility

About

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.

Full 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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

107 participants in 2 patient groups

Extubation Success
Description:
extubation Success which defined as no need of reintubation or tracheostomy after extubation.
Treatment:
Other: No interventation
Extubation Failure
Description:
Extubation Failure was defined as need for any invasive ventilatory support after fist extubation during ICU stay or tracheostomy befor any extubation attempt.
Treatment:
Other: No interventation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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