Electrical Phrenic Nerve Stimulation in Patients With VIDD

Electrical Phrenic Nerve Stimulation in Patients With Ventilator-induced Diaphragm Dysfunction: a Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Diaphragms; Phrenic Nerves
• Intervention / Treatment: Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zongyu Wang, Dr.; Phone Number: 008601082267028; Email: wangzy1976@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Zongyu Wang, Doctor; Phone Number: 86-010-82267028

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcutaneous electrical phrenic nerve stimulation (TEPNS) group; The patients in TEPNS group receive TEPNS and usual care.	Device: 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.
No Intervention: Control group; The patients in control group receive usual care only.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure	Determined from respiratory mechanics indicators provided by ventilator or calculated from them	Collected once a day after TEPNS for consecutive 5 days
Esophageal pressure-time product	Determined from respiratory mechanics indicators provided by ventilator	Collected once a day after TEPNS for consecutive 5 days
Ventilation days	Mechanical ventilation days in 28 days after enrollment	Collected at 28 days after enrollment
Length of ICU stay	Days of ICU stay in 28 days after enrollment	Collected at 28 days after enrollment
28-day mortality	Survival outcomes	Collected at 28 days after enrollment

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Zongyu Wang, Dr., Peking University Third Hospital

Publications and helpful links

General Publications

• Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
• Bao Q, Chen L, Chen X, Li T, Xie C, Zou Z, Huang C, Zhi Y, He Z. The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study. Ann Transl Med. 2022 Oct;10(20):1100. doi: 10.21037/atm-22-4145.
• Medrinal C, Machefert M, Lamia B, Bonnevie T, Gravier FE, Hilfiker R, Prieur G, Combret Y. Transcutaneous electrical diaphragmatic stimulation in mechanically ventilated patients: a randomised study. Crit Care. 2023 Aug 30;27(1):338. doi: 10.1186/s13054-023-04597-1.
• O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256.
• Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.
• Poulard T, Bachasson D, Fosse Q, Nierat MC, Hogrel JY, Demoule A, Gennisson JL, Dres M. Poor Correlation between Diaphragm Thickening Fraction and Transdiaphragmatic Pressure in Mechanically Ventilated Patients and Healthy Subjects. Anesthesiology. 2022 Jan 1;136(1):162-175. doi: 10.1097/ALN.0000000000004042.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ventilator-induced diaphragmatic dysfunction; transcutaneous electrical phrenic nerve stimulation
• Other Study ID Numbers: TEPNS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No