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

NCT ID: NCT04089956

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2023-04-30

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.

Conditions

Traumatic Cervical Spinal Cord Injury (CSCI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Extubation Success

extubation Success which defined as no need of reintubation or tracheostomy after extubation.

No interventation

Intervention Type: OTHER

A retrospective cohort Observational study with no intervention

Extubation Failure

Extubation Failure was defined as need for any invasive ventilatory support after fist extubation during ICU stay or tracheostomy befor any extubation attempt.

No interventation

Intervention Type: OTHER

A retrospective cohort Observational study with no intervention

Interventions

No interventation

A retrospective cohort Observational study with no intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Ling Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LING LIU

Role: STUDY_DIRECTOR

Zhongda Hospital

Locations

Ling Liu

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

20190911

Identifier Type: -

Identifier Source: org_study_id