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

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Threshold inspiratory muscle trainer device; Other: Chest physiotherapy; Other: Adjusting mechanical ventilator trigger sensitivity

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12316
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

• Unstable hemodynamics,
• unstable neurological problems,
• lack of attention and cooperation
• skipping more than five training sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IMT group; Training by inspiratory muscle device plus chest physiotherapy	Other: Threshold inspiratory muscle trainer device; The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.; Other: Chest physiotherapy; Conventional chest physiotherapy
Active Comparator: TS group; Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy	Other: Chest physiotherapy; Conventional chest physiotherapy; 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
Sham Comparator: PT group; Routine chest physiotherapy	Other: Chest physiotherapy; Conventional chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial pressure of oxygen(PaO2)	arterial blood sample was taken and examined thePao2	change from baseline at one week
partial pressure of carbon dioxide(PaCO2)	arterial blood sample was taken and examined the PaCO2	change from baseline at one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate (RR)	Number of respiratory cycles per minute	change from baseline at one week
tidal volume (TV)	volume of air inspired in quiet breathing	change from baseline at one week

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): June 26, 2022
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: December 24, 2022
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ICU2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No