CClinicalTrials.gg
CompletedNCT05846945Updated May 6, 2023

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

An interventional study of Threshold inspiratory muscle trainer device and Adjusting mechanical ventilator trigger sensitivity in Respiratory Failure, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Aug 2021, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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).

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Conditions studied

  • Respiratory Failure
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 90 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    IMT group

    Training by inspiratory muscle device plus chest physiotherapy

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

  • Sham comparator
    PT group

    Routine chest physiotherapy

    Other: Chest physiotherapy

Interventions

  • OtherThreshold inspiratory muscle trainer device

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

  • OtherAdjusting mechanical ventilator trigger sensitivity

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

  • OtherChest physiotherapy

    Conventional chest physiotherapy

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What researchers measure

Primary outcomes

  1. partial pressure of oxygen(PaO2)

    arterial blood sample was taken and examined thePao2

    Time frame: change from baseline at one week

  2. partial pressure of carbon dioxide(PaCO2)

    arterial blood sample was taken and examined the PaCO2

    Time frame: change from baseline at one week

Secondary outcomes

  1. Respiratory rate (RR)

    Number of respiratory cycles per minute

    Time frame: change from baseline at one week

  2. tidal volume (TV)

    volume of air inspired in quiet breathing

    Time frame: change from baseline at one week

07

Study locations

1 site
  • Faculty of Physical Therapy
    Cairo, 12316, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05846945
Lead sponsor
Cairo University
Responsible party
Heba Ahmed Ali Abdeen (Assistant Professor, Cairo University) — Principal investigator
First posted
May 6, 2023
Start date
Aug 12, 2021
Primary completion
Jun 26, 2022
Completion
Jul 10, 2022
Last update
May 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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