Electrical Phrenic Nerve Stimulation in Patients With VIDD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diaphragms Phrenic Nerves

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transcutaneous electrical phrenic nerve stimulation (TEPNS) group

The patients in TEPNS group receive TEPNS and usual care.

Group Type EXPERIMENTAL

transcutaneous electrical phrenic nerve stimulation (TEPNS)

Intervention Type DEVICE

TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath.

Control group

The patients in control group receive usual care only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transcutaneous electrical phrenic nerve stimulation (TEPNS)

TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No