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

• Sponsor: Southeast University, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04089956
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 39.5
• Patients Per Site Per Month: 2.3

Study Details

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	Phase
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 C2 to C7 by the American Spinal Injury Association (ASIA) standard impairment scale grade A，B, and C 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
• Anticipated 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: Sep 15, 2019
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Extubation Success extubation Success which defined as no need for need for ventilatory support after extubation using tracheal intubation or non-invasive mechanical ventilation during ICU stay	Other: No interventation; A retrospective cohort Observational study with no intervention
Extubation Failure Extubation Failure was defined as need for any 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 [up to 90 days]

   extubation Success which defined as no need for need for ventilatory support after extubation using tracheal intubation or non-invasive mechanical ventilation during ICU stay

Secondary Outcome Measures

1. ventilator free days [up to 28 days]

   days of nowvntilation at day 7,14,28

2. complications [up to 90 days]

   complications of mechanication ventilation such as VAP and so on

3. mortality [up to 90 days]

   in-ICU and in hospital mortality

4. length of stay [up to 90 days]

   length of stay in-ICU and in hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. age 18 years or older

2. Traumatic CSCI patients with a neurologic level of injury of C2 to C7 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

	Site	City	State	Country	Postal Code
1	Ling Liu	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

• Southeast University, China

Investigators

• Study Director: LING LIU, Zhongda Hospital Southeast University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ling Liu, Principal Investigator, Southeast University, China
• ClinicalTrials.gov Identifier: NCT04089956
• Other Study ID Numbers: 20190911
• First Posted: Sep 13, 2019
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Principal Investigator, Southeast University, China: spinal cord injury; weaning
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of May 19, 2022