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Role of Aminophylline infusion for Prevention of Ventilator Induced Diaphragmatic Dysfunction in Mechanically Ventilated Patients

Low Dose Aminophylline for Prevention of Ventilator Induced Diaphragmatic Dysfunction in Mechanically Ventilated Patients: A Single Center Randomized Placebo Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074223
Enrollment
60
Registered
2024-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J969- Respiratory failure, unspecified

Interventions

Intervention1: Group A: The patients in Group A will receive aminophylline infusion of 200 mg over one hour, twice a day (Equivalent dose of 320 mg theophylline per day)[1] for 5 days. Control Interve

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients in the age group of 18-75 years admitted in AIIMS ICU with an anticipated duration of mechanical ventilation more than 72 hours will be enrolled in the study. The enrollment will be carried out within 24 hours of onset of mechanical ventilation.

Exclusion criteria

Exclusion criteria: 1. Pre-existing muscular disease 2. Phrenic nerve lesions/ Diaphragmatic palsy 3. Post-Thoracotomy or any Diaphragmatic surgery 4. Pregnant Women 5. Pneumothorax/ Pneumomediastinum 6. Intra-abdominal hypertension 7. Uncontrolled arrythmia, seizures or hyperthyroidism 8. Patients on continuous infusion of Neuromuscular blocking drugs 9. Previous theophylline use. 10. Inability to visualize diaphragm on ultrasound 11. Refusal of consent to participate

Design outcomes

Primary

MeasureTime frame
The goal of this study is to find out the change in diaphragmatic excursion on day 5 with respect to baseline, with the use of low dose aminophylline for 5 days.Timepoint: Day 1, Day 5

Secondary

MeasureTime frame
Change in Diaphragmatic thickening fraction on day 3 and day 5 with respect to baseline.Timepoint: Day 1, Day 3, Day 5;Change in Intercostal muscle contractility with respect to baseline parasternal intercostal muscle thickening fraction (PMTF)Timepoint: Day 1, Day 5;Change in Maximum inspiratory pressureTimepoint: Day 1, Day 5;Change in RSBI (Rapid Shallow Breathing Index)Timepoint: Day 1, Day 5;Length of ICU stayTimepoint: Day 1 to Day of shifting from ICU;Success with SBT (Spontaneous breathing trial)Timepoint: Day 1 to Day of Extubation;Weaning time and Duration of mechanical ventilationTimepoint: Day 1 to Day of Extubation

Countries

India

Contacts

Public ContactDr Bikash Ranjan Ray

All India Institute of Medical Sciences, New Delhi

bikashray.aiims@gmail.com9899323110

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026