Health Condition 1: J00-J99- Diseases of the respiratory system Health Condition 2: I00-I99- Diseases of the circulatory system Health Condition 3: A00-B99- Certain infectious and parasitic diseases Health Condition 4: K00-K95- Diseases of the digestive system Health Condition 5: S00-T88- Injury, poisoning and certain other consequences of external causes
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults more than equal to 18 years old. 2. Receiving invasive mechanical ventilation for more than 48 hours in ICU and met all of the criteria for a Spontaneous Breathing Trial
Exclusion criteria
Exclusion criteria: General patient factors 1. Age under 18 years. 2. Pregnancy. 3. Patients who decline consent, or where consent cannot be obtained (or surrogates have refused consent). 4. Patients with a Do Not Resuscitate / Do Not Re-Intubate order, or those receiving palliative care / undergoing planned withdrawal of life-support (as this can bias outcomes such as re-intubation or need for ventilatory support). Pre-existing neuromuscular or neurologic conditions 5. History of neuromuscular disorders affecting diaphragm function (e.g., known phrenic nerve palsy, myopathy) or other neuromuscular disease. 6. Pre-existing cervical spinal injury (or prior diagnosed spinal cord / neuromuscular disease) that could impair diaphragm innervation or function. 7. Use of neuromuscular-blocking agents within the 48 hours preceding the diaphragm-function assessment (which may interfere with reliable ultrasound or functional evaluation). Findings on ultrasonography or poor image quality 8. Detection (current or prior) of paralysis (no movement) or paradoxical motion of a single hemidiaphragm on diaphragm ultrasonography. 9. Poor-quality ultrasonographic images i.e., when the diaphragm ultrasound window is too poor to allow reliable analysis. Thoracic / respiratory / airway conditions interfering with assessment or extubation safety 10. Recent thoracic surgery, chest trauma, rib fractures, chest wall deformity, pneumothorax or pneumomediastinum any condition that can alter lung mechanics or prevent obtaining an adequate ultrasound window.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the ROSE-SUN composite score integrating diaphragm ultrasound, lung ultrasound score, oxygenation, subcutaneous edema grade, SOFA 2 score, semiquantitative cough strength, and neurological status predicts extubation outcome in mechanically ventilated adult ICU patientsTimepoint: 7 days, 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the predictive performance of ROSE-SUN with any single parameter (e.g., DTF alone, LUS alone, conventional RSBI) or standard clinical judgment. 2. To identify which components among ROSE-SUN will independently contribute most to predicting extubation outcome. 3. To evaluate the feasibility, reproducibility (inter-observer variability), & practicality of implementing ROSE-SUN in routine ICU workflow. 4. To perform subgroup analyses (e.g., ARDS, Sepsis, fluid-overloaded, prolonged ventilation) to assess generalizability & limitations across diverse ICU populations. Timepoint: 7 days, 28 days | — |
Countries
India
Contacts
Public ContactDr Vikas Saini
Postgraduate Institute of Medical Education and Research
Outcome results
None listed