Guillain-Barre SyndromeNCT06167239
Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases
A study testing Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques in people with Guillain-Barre Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2023to 15 Dec 2024
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019).
- Age: >18 years.
- Both sexes will be included.
- Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate < 25.
- Conscious oriented patient with Glasgow coma score ≥13.
- Alertness will be titrated to a Riker Sedation Agitation Score of 4.
Show all 9Show fewer
- PH>7.25, arterial oxygen saturation >90%.
- Cardiovascular stability.
- Maximal inspiratory pressure from 15 to 30 cm H2O and able to trigger spontaneous breaths on ventilator.
Who cannot join
- Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
- Severe breathlessness, when spontaneously breathing.
- Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
- Spinal cord injury.
- Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
- Patients on heavy sedation and respiratory muscle paralysis.
- High peak airway pressure (barotraumas).
- BMI ≥ 40.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail
The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.
Read the detailed description
Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations.
Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.
- Conditions
- Guillain-Barre Syndrome
- Being tested
- Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniquesOther
New techniques to train inspiratory muscles in mechanically ventilated patients
| Study group | Role | What they receive |
|---|---|---|
| Threshold inspiratory muscle trainer | Experimental | Training of the inspiratory muscles by threshold inspiratory muscle trainer. Receives: Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques |
| Ventilator pressure setting inspiratory muscle training | Experimental | Training of the inspiratory muscles by ventilator pressure setting. Receives: Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques |
| Traditional treatment | No intervention | Only prescribed medical treatment programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
PH
To measure PH
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
PaO2
To measure partial pressure of oxygen
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
PaCO2
To measure partial pressure of carbon dioxide
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
HCO3
To measure bicarbonate
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Secondary outcomes (7)
Rapid shallow breathing index
To measure respiratory endurance
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
The Horowitz index
To measure PaO2 /FiO2 ratio
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Glasgow coma scale
To measure level of consciousness
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Riker Sedation-Agitation Scale
Arousal/sedation assessment
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Respiratory rate
Number of breath cycles per minute
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Minute ventilation
The amount of air that enters the lungs per minute.
Measured: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Weaning success rate
Number of patients weaning from MV
Measured: post intervention at the end of the study, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start2 May 2023
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Sayed Essam, Cairo University
- Investigators
- Elmasry, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167239
- Sponsor's protocol ID
- P.T.REC/012/004784
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases in Mechanically Ventilated Patients, a Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT06167239
- Acronym / sponsor ID
- P.T.REC/012/004784
- Conditions
- Guillain-Barre Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 12 Dec 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.
The aim of the current study is to compare the effect of ventilator trigger sensitivity adjustment versus threshold inspiratory muscle training on arterial blood gases in mechanically ventilated patients.
Detailed description
Failed extubations are not uncommon in most ICUs, the failure rate ranging from 2 to 20%. Since failed extubation is associated with greater hospital morbidity and mortality and longer length of stay, it is imperative to identify screening techniques that minimize the number of failed extubations.
Many studies have been done on the effect of IMT by threshold IMT and adjustment of mechanical ventilator trigger separately, thereby, it is rational to compare between two methods of training to know which is more effective to help in weaning process through its effect on ABGs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Threshold inspiratory muscle trainer | Experimental | Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniquesTraining of the inspiratory muscles by threshold inspiratory muscle trainer. |
| Ventilator pressure setting inspiratory muscle training | Experimental | Other: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniquesTraining of the inspiratory muscles by ventilator pressure setting. |
| Traditional treatment | No intervention | –Only prescribed medical treatment programme |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Difficult to wean Guillain barre patients who have been on MV for at least 48 hours. Difficult to wean subjects have been defined as those who fail the first spontaneous breathing trial (SBT)and may require up to 3 SBTs or up to 7 d from the first attempt to achieve successful weaning (B´eduneau G. et al.,2017) and (Annia F. et al.,2019).
- Age: >18 years.
- Both sexes will be included.
- Ventilator mode: Pressure support mode with FiO2≤ 0.5, positive end expiratory pressure (PEEP) will be<8-10cm/H2Oand respiratory rate < 25.
- Conscious oriented patient with Glasgow coma score ≥13.
Key exclusion criteria (8 listed)
- Persistent hemodynamic instability as life threatening arrhythmias, acute heart failure.
- Severe breathlessness, when spontaneously breathing.
- Any progressive neuromuscular disease that would interfere with responding to inspiratory muscle training (non-stationary course).
- Spinal cord injury.
- Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
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 or ventilator pressure setting inspiratory muscle training techniquesNew techniques to train inspiratory muscles in mechanically ventilated patients | Other | Threshold inspiratory muscle trainer, Ventilator pressure setting inspiratory muscle training |
Primary outcome
PH
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
To measure PH
PaO2
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
To measure partial pressure of oxygen
PaCO2
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
To measure partial pressure of carbon dioxide
HCO3
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
To measure bicarbonate
7 secondary outcomes
Rapid shallow breathing index
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
The Horowitz index
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Glasgow coma scale
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Riker Sedation-Agitation Scale
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Respiratory rate
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Minute ventilation
Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks
Weaning success rate
Time frame: post intervention at the end of the study, an average of two weeks
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 21 Oct 2026.
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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.
Elmasry study director
Cairo University
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 or ventilator pressure setting inspiratory muscle training techniques in people with Guillain-Barre Syndrome, 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 9 inclusion and 8 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 21 Oct 2026. 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. 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?
PH (time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks). The study lists 4 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 21 Oct 2026.