Respiratory FailureNCT05846945
Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
A study testing Threshold inspiratory muscle trainer device, Adjusting mechanical ventilator trigger sensitivity and Chest physiotherapy in people with Respiratory Failure, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Threshold inspiratory muscle trainer device, Adjusting mechanical ventilator trigger sensitivity and Chest physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2021to 10 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unstable hemodynamics,
- unstable neurological problems,
- lack of attention and cooperation
- skipping more than five training sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 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).
- Conditions
- Respiratory Failure
- Being tested
- Threshold inspiratory muscle trainer device, Adjusting mechanical ventilator trigger sensitivity, Chest physiotherapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold inspiratory muscle trainer deviceOther
The threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve.
Adjusting mechanical ventilator trigger sensitivityOther
modifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure
Chest physiotherapyOther
Conventional chest physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Active comparator | Training by inspiratory muscle device plus chest physiotherapy Receives: 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 Receives: Other: Adjusting mechanical ventilator trigger sensitivity; Other: Chest physiotherapy |
| PT group | Sham comparator | Routine chest physiotherapy Receives: Other: Chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial pressure of oxygen(PaO2)
arterial blood sample was taken and examined thePao2
Measured: change from baseline at one week
partial pressure of carbon dioxide(PaCO2)
arterial blood sample was taken and examined the PaCO2
Measured: change from baseline at one week
Secondary outcomes (2)
Respiratory rate (RR)
Number of respiratory cycles per minute
Measured: change from baseline at one week
tidal volume (TV)
volume of air inspired in quiet breathing
Measured: change from baseline at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Aug 2021
- Primary completion26 Jun 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846945
- Sponsor's protocol ID
- ICU2022
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05846945
- Acronym / sponsor ID
- ICU2022
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMT group | Active comparator | Other: Threshold inspiratory muscle trainer device, Other: Chest physiotherapyTraining by inspiratory muscle device plus chest physiotherapy |
| TS group | Active comparator | Other: Adjusting mechanical ventilator trigger sensitivity, Other: Chest physiotherapyAdjusting trigger sensitivity of the mechanical ventilator to the lowest pressure tolerated plus chest physiotherapy |
| PT group | Sham comparator | Other: Chest physiotherapyRoutine chest physiotherapy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Unstable hemodynamics,
- unstable neurological problems,
- lack of attention and cooperation
- skipping more than five training sessions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threshold inspiratory muscle trainer deviceThe threshold inspiratory muscle trainer (IMT) device offers resistance to respiration through the spring-loaded valve. | Other | IMT group |
| Adjusting mechanical ventilator trigger sensitivitymodifying the mechanical ventilator trigger sensitivity so that patients can only initiate inspiratory flow by producing more negative intrathoracic pressure | Other | TS group |
| Chest physiotherapyConventional chest physiotherapy | Other | IMT group, PT group, TS group |
Primary outcome
partial pressure of oxygen(PaO2)
Time frame: change from baseline at one week
arterial blood sample was taken and examined thePao2
partial pressure of carbon dioxide(PaCO2)
Time frame: change from baseline at one week
arterial blood sample was taken and examined the PaCO2
2 secondary outcomes
Respiratory rate (RR)
Time frame: change from baseline at one week
tidal volume (TV)
Time frame: change from baseline at one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold inspiratory muscle trainer device, Adjusting mechanical ventilator trigger sensitivity and Chest physiotherapy in people with Respiratory Failure, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
partial pressure of oxygen(PaO2) (time frame: change from baseline at one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.