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protocolized sedation vs non-protocolized sedation in mechanically ventilated patients.

Protocolized sedation utilizing the COMFORT –B scale versus non-protocol-directed sedation in mechanically ventilated children – a randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033130
Enrollment
100
Registered
2021-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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: COMFORT B SCALE: The Comfort-B scale used in this study is a behavioral clinical scale that consists of six factors: alertness, calmness/agitation, respiratory response (or crying, used
scores between 11 and 23 indicate a moderately sedated patient
and scores between 24 and 30 indicate little sedation. Control Intervention1: non protocolied sedation: Mechanically ventilated patients who are under non protocol directed sedation without the use of

Sponsors

pujitha vallabhaneni
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated and admitted in PICU AIIMS JODHPUR for more than 24h. Parents or guardians giving informed written consent for enrollment of child into study.

Exclusion criteria

Exclusion criteria: 1. Patients with neurological disease as the COMFORT B scale cannot be used to determine the level of sedation. 2. Patients requiring deeper sedation for treatment as in pulmonary HTN. 3. Parents and guardians who are not willing to give consent for enrollment of child into study

Design outcomes

Primary

MeasureTime frame
Duration of mechanical ventilation.Timepoint: End of hospital stay

Secondary

MeasureTime frame
amount of usage of various sedative drugs, the frequency of accidental extubation, reintubations, removal of an invasive line, incidence of VAP and pressure ulcers,tracheostomy, incidence of withdrawal symptoms using withdrawal assessment tool- version 1 (WAT 1) in patients on benzodiazepine (BZD) and opioid use, pain between the 2 groups using FLACC and NRS scale for children, PICU and Hospital length of stayTimepoint: End of stay in hospital.

Countries

India

Contacts

Public ContactPujitha Vallabhaneni

AIIMS Jodhpur

daisykhera78@gmail.com9618221731

Outcome results

None listed

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