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

• ClinicalTrials.gov Identifier: NCT04089956
• Recruitment Status: Completed
• First Posted: September 13, 2019
• Last Update Posted: December 27, 2022
• Sponsor: Southeast University, China
• Information provided by (Responsible Party): Ling Liu, Southeast University, China

Study Description

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.

Condition or disease	Intervention/treatment
Traumatic Cervical Spinal Cord Injury (CSCI)	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 Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury
• Actual Study Start Date: June 1, 2014
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: July 30, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. extubation Success [ Time Frame: up to 90 days ]
   defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay

Secondary Outcome Measures :

1. ventilator free days [ Time Frame: up to 28 days ]
   days of nowvntilation at day 7,14,28
2. complications [ Time Frame: up to 90 days ]
   complications of mechanication ventilation such as VAP and so on
3. mortality [ Time Frame: up to 90 days ]
   in-ICU and in hospital mortality
4. length of stay [ Time Frame: up to 90 days ]
   length of stay in-ICU and in hospital

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Traumatic CSCI patients with mechanical ventilation

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

Contacts and Locations

Locations

China, Jiangsu

Ling Liu

Nanjing, Jiangsu, China, 210009

Sponsors and Collaborators

Southeast University, China

Investigators

• Study Director: LING LIU; Zhongda Hospital

More Information

• Responsible Party: Ling Liu, Principal Investigator, Southeast University, China
• ClinicalTrials.gov Identifier: NCT04089956
• Other Study ID Numbers: 20190911
• First Posted: September 13, 2019
• Last Update Posted: December 27, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ling Liu, Southeast University, China:

spinal cord injury; weaning

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System