Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03250481
• Date of registration: 08/08/2017
• Prospective Registration: No
• Primary sponsor: Helsinki University Central Hospital
• Public title: Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients
• Scientific title: Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients
• Date of first enrolment: March 2013
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03250481
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Johanna Wennervirta, MD, PhD
• Affiliation: University of Helsinki and Helsinki University Hospital, PO Box 340, 00029 Helsinki, Finland

Key inclusion & exclusion criteria

Inclusion Criteria:

- Intensive care patients

- Need of mechanical ventilation and sedation

Exclusion Criteria:

- contraindication to propofol or oxycodone

- hypoxic or traumatic brain injury

- intracranial hemorrhage

- status epilepticus

- drug overdose as admission diagnosis



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Critical Illness

Intervention(s)

Drug: Propofol

Primary Outcome(s)

Number of patients with sedation or sedation monitoring related predetermined adverse events [Time Frame: Up to 96 hours (starting when RI-monitoring begins)]

Secondary Outcome(s)

Increased ventilator free days [Time Frame: 30 days]

Secondary ID(s)

HelsinkiUCHFin

Source(s) of Monetary Support

Please refer to primary and secondary sponsors