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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05846945
• Other study ID #: ICU2022
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: July 10, 2022

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 10, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Threshold inspiratory muscle trainer device
The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.
• 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
• Chest physiotherapy
Conventional chest physiotherapy

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial pressure of oxygen(PaO2)	arterial blood sample was taken and examined thePao2	change from baseline at one week
Primary	partial pressure of carbon dioxide(PaCO2)	arterial blood sample was taken and examined the PaCO2	change from baseline at one week
Secondary	Respiratory rate (RR)	Number of respiratory cycles per minute	change from baseline at one week
Secondary	tidal volume (TV)	volume of air inspired in quiet breathing	change from baseline at one week