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

Completed

• Conditions: Traumatic Cervical Spinal Cord Injury (CSCI)
• Interventions: Other: No interventation

• Registration Number: NCT04089956
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Primary Completion: 2022-05-30
• Study Completion: 2023-04-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
extubation Success	up to 90 days	defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay

Secondary Outcome Measures

Name	Time	Method
ventilator free days	up to 28 days	days of nowvntilation at day 7,14,28
complications	up to 90 days	complications of mechanication ventilation such as VAP and so on
mortality	up to 90 days	in-ICU and in hospital mortality
length of stay	up to 90 days	length of stay in-ICU and in hospital

Trial Locations

Locations (1)

Ling Liu; 🇨🇳 Nanjing, Jiangsu, China