Ventilator-based Inspiratory Muscle Training for Patients With Respiratory Failure

NCT07353814 | Not Yet Recruiting

• 1 other identifier: VENTILATOR-BASED TRAINING
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (5)

• Spontaneous breathing trial (SBT)

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

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

• 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.

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

• Duration of MV

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

  from randomization to successful unassisted breathing, up to 48 hours

• 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 %).

  Within 48 hours following extubation

• Extubation success rate

  defined as the proportion of subjects who did not die and were not re-intubated 48-72 hours after the scheduled extubation. The inability to sustain spontaneous breathing after removal of the endotracheal tube, requiring either reintubation or the use of NIV within this specified period, indicates extubation failure (in %).

  Within 72 hours following extubation

Secondary Outcomes (8)

• Blood Gas analysis

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

• Negative Inspiratory Force

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

• Respiratory Rate

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

• Minute Ventilation

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

• Static Lung-Thorax Compliance

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

Study Arms (3)

Conventional Chest Physiotherapy

PLACEBO COMPARATOR

twenty mechanically ventilated patients with acute respiratory failure, who will receive the routine plan of weaning and conventional chest physiotherapy from MV twice a day with a 4-6 hour gap between for 4-5 days a week till extubation.

Other: routine plan of weaning and Conventional Chest Physiotherapy

Trigger Sensitivity IMT

EXPERIMENTAL

twenty mechanically ventilated patients with acute respiratory failure, who will receive inspiratory muscle training by gradual inspiratory flow trigger sensitivity optimization in addition to the routine plan of weaning and conventional chest physiotherapy from MV, twice a day with a 4-6 hour gap between, for 4-5 days a week till extubation.

Other: adjustment of parameters on mechanical ventilation device; Other: routine plan of weaning and Conventional Chest Physiotherapy

Stepwise Pressure Support Reduction IMT

EXPERIMENTAL

twenty mechanically ventilated patients with acute respiratory failure, who will receive inspiratory muscle training via stepwise pressure support reduction in addition to the routine plan of weaning and conventional chest physiotherapy from MV, twice a day with a 4-6 hour gap between, for 4-5 days a week till extubation.

Other: adjustment of parameters on mechanical ventilation device; Other: routine plan of weaning and Conventional Chest Physiotherapy

Interventions

adjustment of parameters on mechanical ventilation device OTHER

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

Stepwise Pressure Support Reduction IMT; Trigger Sensitivity IMT

routine plan of weaning and Conventional Chest Physiotherapy OTHER

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

Conventional Chest Physiotherapy; Stepwise Pressure Support Reduction IMT; Trigger Sensitivity IMT

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• All patients in this study must be hemodynamically and medically stable.
• Patients must be able to trigger spontaneous breaths on the ventilator but couldn't generate maximum inspiratory pressure more than -15 mbar.

You may not qualify if:

• 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.
• Skeletal pathology (scoliosis, flail chest, spinal instrumentation) that would seriously impair the movement of the chest wall and ribs.
• Patients in a coma or under heavy sedation (RASS ≤ -2) and with respiratory muscle paralysis.
• High peak airway pressure (barotrauma), high PEEP \>10, or active pneumothorax.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

kasr Al Ainy Hospital

Cairo, Giza Governorate, 11956, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Mahmoud E Ragab, M.Sc.

  Kasr Al Ainy hospital, Cairo University

  PRINCIPAL INVESTIGATOR

• Nesreen G' EL-NAHAS, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mahmoud E Ragab, MSc

CONTACT

+201001218587; mr.syndrome.264@gmail.com

SHYMAA T Mohamed, PhD

CONTACT

+201021088610; Shimaa.taha395@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: only the investigator knows the applied training method, once randomization is happened and the patient enrolled in his specific group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Dr.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)