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CompletedNCT04089956Updated Jun 27, 2023

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

An observational study in Traumatic Cervical Spinal Cord Injury (CSCI), sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by Southeast University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
107
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Cervical Spinal Cord Injury (CSCI)

Keywords

  • spinal cord injury
  • weaning
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 107 is above the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Traumatic CSCI patients with mechanical ventilation

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
107 participants (actual)
Patient registry
No

Groups and cohorts

  • Extubation Success

    extubation Success which defined as no need of reintubation or tracheostomy after extubation.

    Other: No interventation

  • 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

Interventions

  • OtherNo interventation

    A retrospective cohort Observational study with no intervention

06

What researchers measure

Primary outcomes

  1. extubation Success

    defined as no reintubation after first extubation and no tracheostomy before any extubation attempt during ICU stay

    Time frame: up to 90 days

Secondary outcomes

  1. ventilator free days

    days of nowvntilation at day 7,14,28

    Time frame: up to 28 days

  2. complications

    complications of mechanication ventilation such as VAP and so on

    Time frame: up to 90 days

  3. mortality

    in-ICU and in hospital mortality

    Time frame: up to 90 days

  4. length of stay

    length of stay in-ICU and in hospital

    Time frame: up to 90 days

07

Study locations

1 site
  • Ling Liu
    Nanjing, Jiangsu 210009, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04089956
Lead sponsor
Southeast University, China
Responsible party
Ling Liu (Principal Investigator, Southeast University, China) — Principal investigator
First posted
Sep 13, 2019
Start date
Jun 1, 2014
Primary completion
May 30, 2022
Completion
Apr 30, 2023
Last update
Jun 27, 2023

Study contacts

LING LIU
study director · Zhongda Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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