Diaphragms, Phrenic Nerves
Conditions
Keywords
Ventilator-induced diaphragmatic dysfunction, transcutaneous electrical phrenic nerve stimulation
Brief summary
This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.
Detailed description
Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)\< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.
Interventions
TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged ≥ 18 years * ventilated for at least 48 h with an expected stay of more than 7 days in the ICU * diaphragm thickening fraction (DTF)\< 25%
Exclusion criteria
* having a pacemaker * cutaneous lesion that could interfere with probes * previous diaphragmatic nerve paralysis * body mass index \> 35 kg/m2 * severe chronic obstructive pulmonary disease (FEV1/FVC\<30%) * pregnancy or lactation * decision to withhold life-sustaining treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transdiaphragmatic pressure (Pdi) | Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days | Pdi=gastric pressure - esophageal pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure | Collected once a day after TEPNS for consecutive 5 days | Determined from respiratory mechanics indicators provided by ventilator or calculated from them |
| Esophageal pressure-time product | Collected once a day after TEPNS for consecutive 5 days | Determined from respiratory mechanics indicators provided by ventilator |
| Ventilation days | Collected at 28 days after enrollment | Mechanical ventilation days in 28 days after enrollment |
| Length of ICU stay | Collected at 28 days after enrollment | Days of ICU stay in 28 days after enrollment |
| 28-day mortality | Collected at 28 days after enrollment | Survival outcomes |
Countries
China
Contacts
Primary ContactZongyu Wang, Dr.
Outcome results
None listed