Electrical Phrenic Nerve Stimulation in Patients With VIDD

Last updated: November 10, 2024
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Contraception

Treatment

transcutaneous electrical phrenic nerve stimulation (TEPNS)

Clinical Study ID

NCT06436950
TEPNS_01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: transcutaneous electrical phrenic nerve stimulation (TEPNS)
Phase:
Study Start date:
June 04, 2024
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

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