Electrical Phrenic Nerve Stimulation in Patients With VIDD

NCT06436950 | Recruiting

• 1 other identifier: TEPNS_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragms; Phrenic Nerves

Keywords

Ventilator-induced diaphragmatic dysfunction; transcutaneous electrical phrenic nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Transdiaphragmatic pressure (Pdi)

  Pdi=gastric pressure - esophageal pressure

  Collected once a day after transcutaneous electrical phrenic nerve stimulation (TEPNS) for consecutive 5 days

Secondary Outcomes (5)

• Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure

  Collected once a day after TEPNS for consecutive 5 days

• Esophageal pressure-time product

  Collected once a day after TEPNS for consecutive 5 days

• Ventilation days

  Collected at 28 days after enrollment

• Length of ICU stay

  Collected at 28 days after enrollment

• 28-day mortality

  Collected at 28 days after enrollment

Study Arms (2)

transcutaneous electrical phrenic nerve stimulation (TEPNS) group

EXPERIMENTAL

The patients in TEPNS group receive TEPNS and usual care.

Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

Control group

NO INTERVENTION

The patients in control group receive usual care only.

Interventions

transcutaneous electrical phrenic nerve stimulation (TEPNS) DEVICE

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

transcutaneous electrical phrenic nerve stimulation (TEPNS) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 36388825 BACKGROUND

• 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.

  PMID: 37649092 BACKGROUND

• 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.

  PMID: 32191413 BACKGROUND

• 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.

  PMID: 34625059 BACKGROUND

• 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.

  PMID: 34788380 BACKGROUND

• 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.

  PMID: 32516052 BACKGROUND

Study Officials

• Zongyu Wang, Dr.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongyu Wang, Dr.

CONTACT

008601082267028; wangzy1976@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 31, 2024
• Study Start: June 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-06

Locations

CN (1)