Electrical Phrenic Nerve Stimulation in Patients With VIDD

Peking University

Status: Enrolling

Conditions: Phrenic Nerves; Diaphragms

Treatments: Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06436950

TEPNS_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

transcutaneous electrical phrenic nerve stimulation (TEPNS) group

Experimental group

Description:

The patients in TEPNS group receive TEPNS and usual care.

Treatment:

Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

Control group

No Intervention group

Description:

The patients in control group receive usual care only.