To identify if a set of steps taken in ICU can reduce the muscle weakness developed in ICU

Efficacy of novel bundle of care to reduce ICU acquired weakness- A randomised controlled trail

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034858

Enrollment

124

Registered

2021-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Novel bundle of care to reduce ICU acquired weakness: The following bundle of intervention will be followed 1)NUTRITION : early parenteral feed is avoided, enteral feed pattern in only

Eligibility

Inclusion criteria

Inclusion criteria: a)Patients of either gender 18-70 years b)Predicted ICU stay more than a week c)On invasive mechanical ventilation

Exclusion criteria

Exclusion criteria: a)Patients with pre-existing neuromuscular disorder b)Unconscious (GCS brain injury c) Patients with amputated limbs/Dermatological conditions precluding use of nerve stimulator d)Patients on mechanical ventilation > 72 hours prior to ICU admission e)Malignancy f)Pregnancy g)Malnourished patients with BMI <18.5 kg/m2

Design outcomes

Primary

Measure	Time frame
Incidence of ICU acquired weakness in both groupsTimepoint: Incidence calculation of ICU acquired weakness in each group within the total study period after data collection is completed	—

Secondary

Measure	Time frame
1. Severity of ICUAW as per MRC score on day 5 and day 10 2.Rectus femoris muscle thickness, cross sectional area trend on ultrasound on day 5 and 10 3.Time to development of ICUAW 4. Number of days on ventilator 5. Number of SBT trials before liberation from mechanical ventilation 6. Length of ICU stay 7. Length of hospital stay 8. Muscle power (MRC criteria) at discharge from ICU 9. Time to ambulate after ICU discharge 10. Barthel index at 90 days 11. 90-day mortalityTimepoint: Till hospital discharge or death Barthel index and 90 day mortality by telephonic interview	—

Measure

Time frame

1. Severity of ICUAW as per MRC score on day 5 and day 10 2.Rectus femoris muscle thickness, cross sectional area trend on ultrasound on day 5 and 10 3.Time to development of ICUAW 4. Number of days on ventilator 5. Number of SBT trials before liberation from mechanical ventilation 6. Length of ICU stay 7. Length of hospital stay 8. Muscle power (MRC criteria) at discharge from ICU 9. Time to ambulate after ICU discharge 10. Barthel index at 90 days 11. 90-day mortalityTimepoint: Till hospital discharge or death Barthel index and 90 day mortality by telephonic interview

—

Countries

India

Contacts

Public ContactIvaturi Subha Priyanka

All India Institute Of Medical Sciences New Delhi

drsrajeshwari@gmail.com

Outcome results

None listed

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