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NCT04741399: EXSTATIC
Experiences and Attitudes Towards Agitated Behaviours in TBI ICU Patients: a Protocol for an Interprofessional Mixed-method Study
trial in Trauma Injury in 98 participants. Status unknown.
31 October 2021
Quick facts
| Lead sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 98 |
| Start date | 10 February 2021 |
| Primary completion | 31 October 2021 |
| Estimated completion | 31 October 2021 |
Conditions studied
- Trauma Injury — all drugs for Trauma Injury →
- Intensive Care Neurological Disorder — all drugs for Intensive Care Neurological Disorder →
Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal — full company profile →
Who can join
18 and older, any sex, with Trauma Injury or Intensive Care Neurological Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
EXSTATIC is a multicenter mixed methods convergent study exploring experiences and attitudes of ICU healthcare professionals caring of agitated traumatic brain injury (TBI) patients. The study aims to explore the experiences and attitudes of ICU nurses and other ICU healthcare professionals on the management of agitation in acute TBI patients. This project includes three qualitative methods and one quantitative method. First step consists in structured observations of the daily routine of ICU healthcare professionals when TBI patient admitted in the ICU develops agitation. This step will allow us to raise emerging research questions from the field and to develop subsequent steps. Secondly, we will conduct semi-structured interviews with ICU nurses. Themes emerged in the interviews are essential to understand nurses' experiences and attitudes towards TBI agitated patients and describe their relational role amongst patients, other professionals and families. A retrospective cohort of TBI patients gathered through medical files will follow aiming to document in which way observations in the two first phases are reflected in the clinical notes. Finally, different ICU healthcare professionals will be invited to participate in focus groups to identify further themes in semi-structured interviews in nurses, compare them and prioritize which are the most relevant to nurses experiences and which ones need to be addressed for their future practice. The integration of the different methods will be done using sequential steps of the research (the previous informing the next one) and by the integration of results for each step. Qualitative data will be evaluated following the grounded theory using thematic analysis. Quantitative data will be analysed using descriptive statistics. Qualitative and quantitative results will be combined in a convergent interactive interpretative design. Race and gender perspective will be integrated in collection, analysis and interpretation of data.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
EXperienceS and aTtitudes towards Agitated behaviours in Traumatic brain injury in the Intensive Care unit patients (EXSTATIC): a protocol for an interprofessional mixed-method study.
Saavedra-Mitjans M, David PM, Frenette AJ, Arbour C, et al · · 2021 · cited 2× · PMID 34261680 · DOI 10.1136/bmjopen-2020-045816
Verify or expand the search:
- PubMed search for NCT04741399
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04741399 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Last refreshed: 5 February 2021
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