Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-07-10

Brief Summary

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Ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. Their ages ranged from 50 to 70 years. They were selected from Intensive Care Unit (ICU), Department of Chest Diseases, Cairo University Hospitals. They have randomly assigned into three equal groups. Group (A): trained by threshold IMT device plus routine physical therapy. Group (B): trained by adjusting MV trigger sensitivity plus routine physical therapy. Group (C): only received routine physical therapy. (Negative inspiratory force NIF, arterial blood gases, P/F ration, respiratory rate RR, tidal volume VT, and rapid shallow breathing index RSBI) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).

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Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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IMT group

Training by inspiratory muscle device plus chest physiotherapy

Group Type ACTIVE_COMPARATOR

Threshold inspiratory muscle trainer device

Intervention Type OTHER

The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.

Chest physiotherapy

Intervention Type OTHER

Conventional chest physiotherapy

TS group

Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy

Group Type ACTIVE_COMPARATOR

Adjusting mechanical ventilator trigger sensitivity

Intervention Type OTHER

modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure

Chest physiotherapy

Intervention Type OTHER

Conventional chest physiotherapy

PT group

Routine chest physiotherapy

Group Type SHAM_COMPARATOR

Chest physiotherapy

Intervention Type OTHER

Conventional chest physiotherapy

Interventions

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Threshold inspiratory muscle trainer device

The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.

Intervention Type OTHER

Adjusting mechanical ventilator trigger sensitivity

modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure

Intervention Type OTHER

Chest physiotherapy

Conventional chest physiotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Their age ranged from 50-70 years.
* The patients were diagnosed with acute respiratory failure duo to COPD exacerbation and need mechanical ventilation support for more than 48 hours.
* They were vitally stable and can tolerate pressure support
* PEEP less than 8Cm H2O , SpO2 more than 90).
* All patients were conscious and responded to verbal command.