Health TrialsbyHealthPanel

Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

ConditionsRespiratory FailureMechanical Ventilation Complication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-55
SponsorCairo University

About this trial

This study will be conducted to compare the effectiveness of progressive inspiratory flow trigger sensitivity rising versus stepwise pressure support reduction as ventilator-based inspiratory muscle training methods on weaning and extubation success in mechanically ventilated patients with respiratory failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute respiratory failure patients in the ICU are receiving MV for 48 h or more in a controlled mode.

Their ages will range from 40 to 55 years old, and both sexes will be included.

Conscious and oriented patients with a Glasgow coma score ≥13 (≥9T).

Alertness score with a Richmond Agitation-Sedation Scale (RASS) will be from 0 to -1.

Disqualifiers

Persistent hemodynamic instability as life-threatening conditions or comorbidities interfere with and compromise weaning, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or acute coronary syndrome.

Severe breathlessness when spontaneously breathing.

Any progressive neuromuscular disease, such as myopathy or neuropathy, that would interfere with responding to inspiratory muscle training due to inadequate training performance of the inspiratory muscle.

Spinal cord injury.

Trial design

Design model

Parallel

Treatments tested in this trial

  • adjustment of parameters on mechanical ventilation device

    Other intervention

    adjust the parameters of the mode of training on mechanical ventilation according the group of patients

  • routine plan of weaning and Conventional Chest Physiotherapy

    Other intervention

    Chest Physiotherapy including: ▪ Postural Drainage ▪ Manual techniques for airway clearance (percussion, vibration, shaking) Adding to range of passive to active movements of the limbs

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Conventional Chest PhysiotherapyPlacebo comparator 1 intervention
Group B: Trigger Sensitivity IMTExperimental treatment 2 interventions
Group C: Stepwise Pressure Support Reduction IMTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Spontaneous breathing trial (SBT)

documenting the frequency (total number) of spontaneous breathing trials for each patient until successful extubation

Time frame
From initiation of the first SBT until successful extubation, up to 48 hours
2

Burn's Wean Assessment Score

Calculate the percentage of the total score to indicate the extent of improvement and the probable readiness for weaning (in %). The 26-item checklist assigns 1 point for "yes" responses, with a total score up to 26. Scores below 17 (65%) suggest insufficient readiness for weaning, while scores ≥ 17 indicate probable readiness for weaning.

Time frame
baseline (Day 1, prior to intervention) and immediately before initiation of successful SBT
3

Duration of MV

defined as the time from study randomization to successful unassisted breathing (in days)

Time frame
from randomization to successful unassisted breathing, up to 48 hours
4

weaning success rate

absence of ventilatory support 48 hours after discontinuation of MV. Inability to tolerate or pass SBT or to be liberated from invasive ventilatory support indicates weaning failure (in %).

Time frame
Within 48 hours following extubation

Secondary outcomes

1

Blood Gas analysis

Measure the results of the arterial blood gas analysis before beginning the intervention and follow up on its progression through the study and get the final results once weaning occurs. Lower PaCO₂ during MV is independently associated with successful weaning, while higher levels are linked to weaning failure

Time frame
baseline (Day 1, prior to intervention) and within 48 hours after liberation from mechanical ventilation
2

Negative Inspiratory Force

Negative inspiratory force (cmH₂O) will be measured via the mechanical ventilator as an index of global inspiratory muscle strength, consistent with ATS/ERS recommendations for weaning assessment.

Time frame
Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
3

Respiratory Rate

Respiratory rate (breaths/min) will be measured from the mechanical ventilator as an indicator of respiratory load and breathing pattern

Time frame
Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT
4

Minute Ventilation

Minute ventilation (L/min) will be measured from the mechanical ventilator.

Time frame
Baseline (Day 1, prior to intervention) and immediately following completion of successful SBT

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

kasr Al Ainy Hospital Status unavailable 11956, Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: