Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II)

NCT05238753 | Terminated

• 1 other identifier: STIMIT-II
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible. In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

Conditions

Muscle Weakness; Critical Illness; Mechanical Ventilation Complication

Keywords

VIDD; ICUAW; Muscle Weakness; Weaning

Outcome Measures

Primary Outcomes (3)

• Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.

  Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol.

  10 days

• Time to find the optimal stimulation point of the N. phrenicus

  Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds

  Study duration (10 days)

• Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight)

  Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator.

  Study duration (10 days)

Secondary Outcomes (12)

• Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve

  Study duration (10 days)

• Correlation between amplitude and duration of sEMG signals during stimulated breathing.

  Study duration (10 days)

• Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve

  Study duration (10 days)

• Occlusion pressure during electromagnetical stimulation of the phrenic nerve

  Study duration (10 days)

• Diaphragm thickening fraction

  approx. 28 days (till ICU discharge)

Study Arms (2)

Intervention, stimulated

EXPERIMENTAL

Electromagnetic stimulation of the phrenic nerve in critically ill patients.

Device: Non-invasive electromagnetic stimulation

Control, not stimulated

NO INTERVENTION

Control group, no stimulation of the phrenic nerve.

Interventions

Non-invasive electromagnetic stimulation DEVICE

Non-invasive bilateral electromagnetic stimulation of the phrenic nerve

Intervention, stimulated

Eligibility Criteria

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

You may qualify if:

• Patients between 18 and 60 years old, hospitalized in ICU
• Mechanical ventilation \< 36 h
• Prone to stay ventilated \> 72 h

You may not qualify if:

• Known neurological condition affecting motor neuron or muscle (e.g. ALS)
• Known paralysis of the phrenic nerve
• Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
• Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
• Not able to read and understand the national language German
• Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
• Patients with implanted medical pumps
• Pregnant patients
• Patients with skin lesions, infections or strictures in throat/neck area
• Patients with metallic implants

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Stimit AG: collaborator

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Panelli A, Grimm AM, Krause S, Verfuss MA, Ulm B, Grunow JJ, Bartels HG, Carbon NM, Niederhauser T, Weber-Carstens S, Brochard L, Schaller SJ. Noninvasive Electromagnetic Phrenic Nerve Stimulation in Critically Ill Patients: A Feasibility Study. Chest. 2024 Sep;166(3):502-510. doi: 10.1016/j.chest.2024.02.035. Epub 2024 Feb 24.

  PMID: 38403186 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes

Study Officials

• Stefan J Schaller, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Director

Model Details: 15 patients in control group, 15 patients in interventional group with sequential design in term of daily frequency of non-invasive electromagnetic phrenic nerve stimulation, i.e. starting with 5 patients with 2 stimulation per day, followed by 5 patients with 3 stimulations and 5 patients with 5 stimulations per day

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: January 21, 2022
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of scientific manuscript.
• Access Criteria: Deidentified data can be requested on reasonable scientific request.

Locations

DE (1)