## Protocol Section
### Identification Module
**NCT ID:** NCT06436950

**Brief Title:** Electrical Phrenic Nerve Stimulation in Patients With VIDD

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

#### Organization Study ID Info
**ID:** TEPNS_01
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University Third Hospital

#### Responsible Party

**Investigator Affiliation:** Peking University Third Hospital

**Investigator Full Name:** Wang Zongyu

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diaphragms

- Phrenic Nerves

**Keywords:**

- Ventilator-induced diaphragmatic dysfunction

- transcutaneous electrical phrenic nerve stimulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Transcutaneous electrical phrenic nerve stimulation (TEPNS) group: TEPNS+usual care Control group: usual care

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients in TEPNS group receive TEPNS and usual care.

**Intervention Names:**

- Device: transcutaneous electrical phrenic nerve stimulation (TEPNS)

**Label:** transcutaneous electrical phrenic nerve stimulation (TEPNS) group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The patients in control group receive usual care only.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- transcutaneous electrical phrenic nerve stimulation (TEPNS) group

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

**Name:** transcutaneous electrical phrenic nerve stimulation (TEPNS)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Pdi=gastric pressure - esophageal pressure

**Measure:** Transdiaphragmatic pressure (Pdi)

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

#### Secondary Outcomes

**Description:** Determined from respiratory mechanics indicators provided by ventilator or calculated from them

**Measure:** Airway pressure, esophageal pressure, gastric pressure, airway occlusion pressure, driving pressure, transpulmonary pressure

**Time Frame:** Collected once a day after TEPNS for consecutive 5 days

**Description:** Determined from respiratory mechanics indicators provided by ventilator

**Measure:** Esophageal pressure-time product

**Time Frame:** Collected once a day after TEPNS for consecutive 5 days

**Description:** Mechanical ventilation days in 28 days after enrollment

**Measure:** Ventilation days

**Time Frame:** Collected at 28 days after enrollment

**Description:** Days of ICU stay in 28 days after enrollment

**Measure:** Length of ICU stay

**Time Frame:** Collected at 28 days after enrollment

**Description:** Survival outcomes

**Measure:** 28-day mortality

**Time Frame:** Collected at 28 days after enrollment

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wangzy1976@126.com

**Name:** Zongyu Wang, Dr.

**Phone:** 008601082267028

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Zongyu Wang, Doctor

- **Phone:** 86-010-82267028

- **Role:** CONTACT

**Country:** China

**Facility:** Peking University Third Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100191

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University Third Hospital

**Name:** Zongyu Wang, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
