Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services Health Condition 2: J962- Acute and chronic respiratory failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients on day 2 to day 4 of mechanical ventilation [volume control ventilation: VCV mode] with oro-tracheal intubation between 18 to 70 years weighing 50 to 75 kgs (2) experiencing agitation on mechanical ventilation [RAAS +1 to +3]
Exclusion criteria
Exclusion criteria: (1) patient is extremely agitated posing a danger to healthcare providers [RASS +4] (2) patient already sedated [RASS below -1], delirious, with cognitive disabilities, decreased consciousness, comatose or brain dead (3) history of bilateral hearing loss (4) history of known psychiatric diseases or known addictions to psychoactive substances or opioids (5) patients with unstable haemodynamics (6) pregnant (7) trauma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY AIM IS TO COMPARE THE EFFECTIVENESS OF 30 MINUTES OF INTERVENTION RAGA AHIR BHAIRAV MUSIC , 528HZ MUSIC ,SINGLE DOSE INTRAVENOUS MIDAZOLAM (0.05mg/kg) AND A PLACEBO INTERVENTION (USE OF HEADPHONES WITHOUT PLAYING ANY MUSIC) ON AGITATION AMONG MECHANICALY VENTILATED PATIENTS BY MEASURING RASS (RICHMOND AGITATION AND SEDATION SCALE)SCORETimepoint: ASSESMENT OF RASS (RICHMOND AGITATION AND SEDATION SCALE) SCORE BEFORE AND AFTER EACH INTERVENTION OF 30 MIN | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of 528 Hz music (30 minutes), Raga Ahir Bhairav music (30 minutes), single dose intravenous midazolam (0.05 mg/kg: for 50 to 75 kg patients) and a placebo intervention on heart rate (HR), systolic blood pressure (sBP), diastolic blood pressure (dBP), mean BP (MBP), respiratory rate (RR), oxygen saturation (SpO2), mean airway pressure and pain (measured by critical care pain observation tool). To compare the usage of rescue medicine [in form of intravenous fentanyl (1 microgram/ kg)] if any to control increased agitation [RASS +4], in the four groups.Timepoint: o compare the effectiveness of 528 Hz music (30 minutes), Raga Ahir Bhairav music (30 minutes), single dose intravenous midazolam (0.05 mg/kg) and a placebo intervention (use of headphones without playing any music) on agitation [measured by Richmond agitation and sedation scale: RASS] among patients on mechanical ventilation admitted in an ICU of a tertiary care hospital, Kolkata. | — |
Countries
India
Contacts
KPC MEDICAL COLLEGE AND HOSPITAL