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

NCT ID: NCT05238753

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2022-05-15

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.

Detailed Description

During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.

Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention, stimulated

Electromagnetic stimulation of the phrenic nerve in critically ill patients.

Group Type: EXPERIMENTAL

Non-invasive electromagnetic stimulation

Intervention Type: DEVICE

Non-invasive bilateral electromagnetic stimulation of the phrenic nerve

Control, not stimulated

Control group, no stimulation of the phrenic nerve.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-invasive electromagnetic stimulation

Non-invasive bilateral electromagnetic stimulation of the phrenic nerve

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stimit AG

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Stefan J Schaller

Deputy Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Univiversitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 38403186 (View on PubMed)

Other Identifiers

STIMIT-II

Identifier Type: -

Identifier Source: org_study_id