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Recruiting NCT06167239

Ventilator Trigger Sensitivity Adjustment Versus Threshold Inspiratory Muscle Training on Arterial Blood Gases

No phase Interventional Guillain-Barre Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques.
Who it may be relevant to
Registry conditions: Guillain-Barre Syndrome. Basic parameters: 20 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Threshold inspiratory muscle trainer or ventilator pressure setting inspiratory muscle training techniques
    New techniques to train inspiratory muscles in mechanically ventilated patients

Primary outcome measures

  • PH [Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
  • PaO2 [Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
  • PaCO2 [Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
  • HCO3 [Time frame: Pre intervention and immediate post intervention, through study completion, an average of two weeks]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Kasr Al Ainy School of Medicine — Cairo

Identifiers

NCT: NCT06167239 · P.T.REC/012/004784

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗