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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Cervical Spinal Cord Injury (CSCI)
• Intervention / Treatment: Other: No interventation

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 Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

• Study Contact: Name: Ling Liu; Phone Number: +8613851435472 +8613851435472; Email: liulingdoctor@126.com
• Study Contact Backup: Name: Xiaoting Xu; Phone Number: +8613645188041 +8613645188041; Email: xuxiaoting2005@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Ling Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Traumatic CSCI patients with mechanical ventilation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extubation Success; extubation Success which defined as no need of reintubation or tracheostomy after extubation.	Other: No interventation; 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.	Other: No interventation; A retrospective cohort Observational study with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation Success	defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay	up to 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Ling Liu, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: weaning; spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 20190911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No