Efficacy and economic evaluation of delivery of care with Tele-continuous EEG monitoring in critically ill patients: A multicenter randomized controlled trial

Phase 4

Completed

• Conditions: Critically ill patients with altered mental status; Tele-cEEG; Tele-rEEG; critically ill patients; Randomized controlled trial.

• Registration Number: TCTR20181022002
• Lead Sponsor: The Thailand Research Fund (TRF)

Brief Summary

Tele-cEEG may benefit helping detect NCS/NCSE. However, its efficacy on reducing mortality and improving functional outcome was not demonstrated in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Study Completion: 2023-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

1. Patients without following conditions Post cardiac arrest, Advanced stage cancer stage IV, AIDs CD4 count less than 200 cells per mm3 or with certain opportunistic infections, Alcoholic intoxication with or without delirium tremens, and Extensive lacerations, skin lesions, or surgical wound where the electrode placement is not possibly applied.
2. Patients with one of the following conditions;
Recent clinical seizure/status epilepticus without return to baseline, Severely depressed consciousness from any cause with GCS less than 8, Intracranial hemorrhages with more than low probability of survival, including traumatic brain injury, subarachnoid hemorrhage, and intracerebral hemorrhage, Suspected NCS or NCSE in patients with altered mental status, Central nervous system infection with altered mental status

Exclusion Criteria

Patients with survival less than 72 hours after randomization
Patients who maintain EEG monitoring < 12 h in Tele-cEEG and < 20 min in Tele-rEEG arm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome 3, 7 days after EEG recording, at discharge, 90 days, 6 months, and 1 year after discharge Modified Rankin Scale,All-cause mortality at discharge and at 1 year case-fatality rate and crude annual mortality rate,Incidence of seizures during admission cumulative incidence

Secondary Outcome Measures

Name	Time	Method
Cost at discharge, 90 days, 6 months, 1 year after discharge total costs in Baht,HRQoL at 90 days, 1 year after discharge EQ-5D-5L (Thai version),ICU and hospital lenght of stay at discharge days,Satisfactions at discharge, 1 year after discharge satisfaction score,Changing of medical decision at discharge percentage