Diaphragm Training Ultrasound

NCT ID: NCT04186325

Last Updated: 2024-03-15

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-28

Study Completion Date

2025-12-31

Brief Summary

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Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult.

Mechanical ventilation after endotracheal intubation predisposes these patients to an increased incidence of pulmonary complications such as ventilator-associated pneumonia (VAP), increased risk of deep vein thrombosis, bedsores, increased hospital stay, and poor clinical outcome.

The weaning process from MV involves the reduction of ventilator parameters and Extubation. Daily, careful evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the MV.

The diaphragm which is the principal respiratory muscle provides nearly 75% of the resting pulmonary ventilation. However, In ICU patients, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis. Diaphragmatic dysfunction and atrophy is the main precipitating factor for difficult and successful weaning.

Detailed Description

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Conditions

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DIAPHRAGM -Ultrasound -Weaning -Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group C

Group C: the regular mechanical ventilation protocol will be followed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group T

Group T: inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.

Group Type EXPERIMENTAL

DIAPHRAGMATIC exercising

Intervention Type PROCEDURE

inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.

Interventions

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DIAPHRAGMATIC exercising

inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients attached to mechanical ventilation will be included in the study after the informed consent of the legal guardian.

Exclusion Criteria

* Patients with severe acute lung injury, morbid obesity, chest wall deformity, direct diaphragmatic injury, cervical spine and patients who require neuromuscular infusion will be excluded from the study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University-Emergency hospital-ICU

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maha Abozeid, MD

Role: CONTACT

02-01019216192

Facility Contacts

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Maha Abozeid, MD

Role: primary

00201019216192

Other Identifiers

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diaphragm ultrasound

Identifier Type: -

Identifier Source: org_study_id

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