Electrical Phrenic Nerve Stimulation in Patients With VIDD

Not Applicable

Recruiting

• Conditions: Diaphragms; Phrenic Nerves
• Interventions: Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

• Registration Number: NCT06436950
• Lead Sponsor: Peking University Third Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-26
• Study First Posted: 2024-05-31
• Status Verified: 2024-06
• Study Start: 2024-06-04
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcutaneous electrical phrenic nerve stimulation (TEPNS) group	transcutaneous electrical phrenic nerve stimulation (TEPNS)	The patients in TEPNS group receive TEPNS and usual care.

Primary Outcome Measures

Name	Time	Method
Transdiaphragmatic pressure (Pdi)	Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days	Pdi=gastric pressure - esophageal pressure

Secondary Outcome Measures

Name	Time	Method
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
28-day mortality	Collected at 28 days after enrollment	Survival outcomes
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
Length of ICU stay	Collected at 28 days after enrollment	Days of ICU stay in 28 days after enrollment

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China