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Completed

NCT Number: NCT04089956

EAdi as a Predictor of Successful 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.

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Key information

Conditions

Traumatic Cervical Spinal Cord Injury (CSCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ling Liu

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 to D
  • patients with mechanical ventilation due to acute respiratory failure and admit to ICU
  • with dedicated nasogastric tube with nine electrodes that allow to continuously measure diaphragm electrical activity (EAdi catheter, Maquet, Solna, Sweden) in position.

Exclusion criteria

  • tracheostomy before ICU admission
  • withhold or withdraw life sustaining treatment due to other serious organ injury
  • can't complete instructional actions,
  • death occurred within 7 days after injury
  • postoperative MV was a direct result of surgery and had duration of less than 24 hours postoperatively.
  • EAdi data not available

Treatment and study plan

No interventation

Other

A retrospective cohort Observational study with no intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
Sep 13, 2019
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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