Effect of Early Non-invasive Phrenic Nerve Stimulation on Weaning in Mechanically Ventilated Patients

NCT ID: NCT05629819

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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the early application of non-invasive PNS in MV patients can increase the number of days without mechanical ventilation, delay disuse phrenic atrophy, and improve the strength of inspiratory muscle.

Detailed Description

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A prospective randomized controlled study included 104 patients with MV who met inclusion criteria in multiple hospital ICU units and were randomly divided 1:1 into PNS and conventional groups. The PNS group received neuromuscular electrical stimulation in addition to routine airway management, early activity and respiratory muscle training. It was verified that early non-invasive PNS could increase the number of days without mechanical ventilation for 28 days, delay disused diaphragm atrophy and improve inspiratory muscle strength.

Conditions

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Mechanical Ventilation Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients enrolled in the study were unaware of the study

Study Groups

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PNS group

In addition to conventional respiratory therapy and pulmonary rehabilitation, neuromuscular electrical stimulator was used for PNS

* Device Settings Strength: Maximum current tolerated by the patient (0-100mA, commonly used below 13mA) ; Stimulation time: 1.0s; Frequency: 40Hz;
* Location: The stimulation electrodes were attached to the left and right sides of the neck under the outer margin of the sternocleidomastoid muscle 1/3; The reference electrodes were attached to the surface of both pectoralis major muscles.
* Treatment frequency: 30 at a time, Bid, until withdrawal/death/for 4 weeks.

Group Type EXPERIMENTAL

Non-invasive phrenic nerve stimulation

Intervention Type DEVICE

Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.

conventional group

* conventional respiratory therapy and pulmonary rehabilitation, including airway management, early activity, and respiratory muscle training.
* No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Non-invasive phrenic nerve stimulation

Some studies have shown that PNS can relieve diaphragmatic atrophy and reverse diaphragmatic dysfunction.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18years and ≤80years;
* MV time ≤48h;
* MV duration is expected to be ≥72h;
* The sternocleidomastoid region and pectoralis major region were completely exposed.
* Patients or family members are willing to sign informed consent and participate in the study.

Exclusion Criteria

* There are contraindications to PNS in vitro (Pneumothorax, active tuberculosis, pleural adhesions, installation of pacemakers and defibrillators, etc.);
* Neuromuscular disease (myasthenia gravis, etc.) or known anatomical abnormalities of the diaphragm;
* ECMO status;
* Hemodynamic instability;
* Uncorrected arrhythmias;
* Be pregnant;
* Clinical end-stage and palliative care patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bing Sun

OTHER

Sponsor Role lead

Responsible Party

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Bing Sun

professor of treatment

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bing Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Bing Sun

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Wang, B.S.Nurs

Role: CONTACT

86015910268323

Bing Sun, MD

Role: CONTACT

86013911151075

Facility Contacts

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Bing Sun, MD

Role: primary

+8613911151075

Li Wang, B.S.Nurs

Role: backup

+8615910268323

Other Identifiers

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PNS in MV patients

Identifier Type: -

Identifier Source: org_study_id

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