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

NCT05846945 | Completed

• 1 other identifier: ICU2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Respiratory rate (RR)

  change from baseline at one week

• tidal volume (TV)

  change from baseline at one week

Study Arms (3)

IMT group

ACTIVE COMPARATOR

Training by inspiratory muscle device plus chest physiotherapy

Other: Threshold inspiratory muscle trainer device; Other: Chest physiotherapy

TS group

ACTIVE COMPARATOR

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

Other: Adjusting mechanical ventilator trigger sensitivity; Other: Chest physiotherapy

PT group

SHAM COMPARATOR

Routine chest physiotherapy

Other: Chest physiotherapy

Interventions

Threshold inspiratory muscle trainer device OTHER

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

IMT group

Adjusting mechanical ventilator trigger sensitivity OTHER

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

TS group

Chest physiotherapy OTHER

Conventional chest physiotherapy

IMT group; PT group; TS group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: May 6, 2023
• Study Start: August 12, 2021
• Primary Completion: June 26, 2022
• Study Completion: July 10, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)