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

Traumatic Cervical Spinal Cord Injury (CSCI) Clinical Trial

Official title:

Diaphragm Electrical Activity in "Spontaneous Breathing Challenge" Reliably Predict Early Extubation in Patients With Traumatic Cervical Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089956
• Other study ID #: 20190911
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 30, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Traumatic Cervical Spinal Cord Injury (CSCI)
• Wounds and Injuries

Intervention

Other:
• No interventation
A retrospective cohort Observational study with no intervention

Locations

Country	Name	City	State
China	Ling Liu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extubation Success	defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay	up to 90 days
Secondary	ventilator free days	days of nowvntilation at day 7,14,28	up to 28 days
Secondary	complications	complications of mechanication ventilation such as VAP and so on	up to 90 days
Secondary	mortality	in-ICU and in hospital mortality	up to 90 days
Secondary	length of stay	length of stay in-ICU and in hospital	up to 90 days