Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT05358132
Eligibility Criteria:
Inclusion Criteria:
Group 1 - Acute toxicity group
* Presentation to ED due to presumed overdose of drug with potential for respiratory depression (intentional, accidental, recreational, therapeutic excess)
* At least one of GCS \<15 or respiratory depression or risk of deterioration of GCS or respiration.
* Age \>16 years
* Are willing and able to give informed consent or have available next of Kin to provide informed consent on the participant's behalf
* Able (in the Investigators opinion) and willing to comply with all study requirements
Group 2 - PSA group
* Patient undergoing procedural sedation and anaesthesia in ED
* Age \>16 years
* Are willing and able to give informed consent
* Able (in the Investigators opinion) and willing to comply with all study requirements
* Can speak and read English
Exclusion Criteria:
Group 1 - Acute toxicity group
* Unable to provide consent and no next of kin to provide consent on participant's behalf
* Impaired consciousness / respiratory suppression most likely due to cause other than acute drug use
* Condition primarily related to alcohol use and no evidence of acute drug use
* Condition due to withdrawal of drugs / alcohol.
* Treating clinician deems patient inappropriate to be included in study
Group 2 - PSA group
* Unable to provide consent
* Treating clinician deems patient inappropriate to be included in study
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05358132
Study Brief:
Protocol Section:
NCT05358132