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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Threshold inspiratory muscle trainer device
Adjusting mechanical ventilator trigger sensitivity
Chest physiotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

IMT group

TS group

PT group

Arm Description

Training by inspiratory muscle device plus chest physiotherapy

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

Routine chest physiotherapy

Outcomes

Primary Outcome Measures

partial pressure of oxygen(PaO2)
arterial blood sample was taken and examined thePao2
partial pressure of carbon dioxide(PaCO2)
arterial blood sample was taken and examined the PaCO2

Secondary Outcome Measures

Respiratory rate (RR)
Number of respiratory cycles per minute
tidal volume (TV)
volume of air inspired in quiet breathing

Full Information

First Posted
December 24, 2022
Last Updated
April 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05846945
Brief Title
Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
Official Title
Effect of Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
June 26, 2022 (Actual)
Study Completion Date
July 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT group
Arm Type
Active Comparator
Arm Description
Training by inspiratory muscle device plus chest physiotherapy
Arm Title
TS group
Arm Type
Active Comparator
Arm Description
Adjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy
Arm Title
PT group
Arm Type
Sham Comparator
Arm Description
Routine chest physiotherapy
Intervention Type
Other
Intervention Name(s)
Threshold inspiratory muscle trainer device
Intervention Description
The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.
Intervention Type
Other
Intervention Name(s)
Adjusting mechanical ventilator trigger sensitivity
Intervention Description
modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy
Intervention Description
Conventional chest physiotherapy
Primary Outcome Measure Information:
Title
partial pressure of oxygen(PaO2)
Description
arterial blood sample was taken and examined thePao2
Time Frame
change from baseline at one week
Title
partial pressure of carbon dioxide(PaCO2)
Description
arterial blood sample was taken and examined the PaCO2
Time Frame
change from baseline at one week
Secondary Outcome Measure Information:
Title
Respiratory rate (RR)
Description
Number of respiratory cycles per minute
Time Frame
change from baseline at one week
Title
tidal volume (TV)
Description
volume of air inspired in quiet breathing
Time Frame
change from baseline at one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
ZIP/Postal Code
12316
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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