Clinical trial NCT04089956: EAdi as a Predictor of Successful Extubation in Patients With Traumatic Cervical Spinal Cord Injury
Official title: Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Cervical Spinal Cord Injury (CSCI)
Keywords: spinal cord injury
weaning
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic CSCI patients with mechanical ventilation

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.

Eligibility criteria: 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

Primary outcomes:
measure: extubation Success
timeFrame: up to 90 days
Secondary outcomes:
measure: ventilator free days
timeFrame: up to 28 days
measure: complications
timeFrame: up to 90 days
measure: mortality
timeFrame: up to 90 days
measure: length of stay
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Ling Liu
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: LING LIU
role: STUDY_DIRECTOR
References: