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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05846945

Collaborator

(none)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Other: Threshold inspiratory muscle trainer device Other: Adjusting mechanical ventilator trigger sensitivity Other: Chest physiotherapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 12, 2021

Actual Primary Completion Date :

Jun 26, 2022

Actual Study Completion Date :

Jul 10, 2022

Arms and Interventions

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: 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 Other: Chest physiotherapy Conventional chest physiotherapy
Sham Comparator: PT group Routine chest physiotherapy	Other: Chest physiotherapy Conventional chest physiotherapy

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: 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

Other: Chest physiotherapy

Conventional chest physiotherapy

Sham Comparator: PT group

Routine chest physiotherapy

Other: Chest physiotherapy

Conventional chest physiotherapy

Outcome Measures

Primary Outcome Measures

partial pressure of oxygen(PaO2) [change from baseline at one week]
arterial blood sample was taken and examined thePao2
partial pressure of carbon dioxide(PaCO2) [change from baseline at one week]
arterial blood sample was taken and examined the PaCO2

Secondary Outcome Measures

Respiratory rate (RR) [change from baseline at one week]
Number of respiratory cycles per minute
tidal volume (TV) [change from baseline at one week]
volume of air inspired in quiet breathing

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy	Cairo		Egypt	12316

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heba Ahmed Ali Abdeen, Assistant Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05846945

Other Study ID Numbers:

ICU2022

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of May 6, 2023