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OpenTrials
Completed

NCT Number: NCT05846945

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).

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Threshold inspiratory muscle trainer device

Other

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

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

chest physiotherapy

Other

Conventional chest physiotherapy

Primary outcomes

  1. partial pressure of oxygen(PaO2)

    Time frame: change from baseline at one week

    arterial blood sample was taken and examined thePao2

  2. partial pressure of carbon dioxide(PaCO2)

    Time frame: change from baseline at one week

    arterial blood sample was taken and examined the PaCO2

Secondary outcomes

  1. Respiratory rate (RR)

    Time frame: change from baseline at one week

    Number of respiratory cycles per minute

  2. tidal volume (TV)

    Time frame: change from baseline at one week

    volume of air inspired in quiet breathing

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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