---
title: "Self-management of Sedation by Mechanically Ventilated Patients: Randomized Trial Results"
id: "pubmed-42554300"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42554300"
content_type: "clinical_feed_article"
specialty: "Critical Care"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42554300/"
doi: "10.1093/annalsats/aaoag233"
published_at: "2026-08-05T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Self-management of Sedation by Mechanically Ventilated Patients: Randomized Trial Results
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42554300
- **Specialty:** [Critical Care](https://medichelpline.com/clinical-feed/critical-care.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42554300/)
- **DOI:** [10.1093/annalsats/aaoag233](https://doi.org/10.1093%2Fannalsats%2Faaoag233)
- **Published At:** 2026-08-05T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This randomized, open-label, multicenter trial tested patient **self-management** of sedative therapy versus usual nurse-administered care in adults receiving invasive **mechanical ventilation**. - 161 patients were enrolled across five Midwestern hospitals and randomized 1:1 to usual care (n = 81) or intervention (n = 80) using center-stratified blocks. - Intervention patients used a push-button device to self-administer **dexmedetomidine** boluses (0.25 mcg/kg) up to three times per hour with 20-minute lockouts; a basal infusion (0.2 mcg/kg/hr) was started and adjusted by nurses between 0.1–0.7 mcg/kg/hr based on recent bolus use. - Patients reported anxiety three times daily using a 0–100 visual analog scale (VAS); anxiety over time was analyzed with linear mixed-effects models. - Primary comparisons included self-reported anxiety, duration of mechanical ventilation, and incidence of delirium measured by CAM-ICU; delirium analyzed via generalized estimating equations. - Median time on protocol was 88 hours; median age was 62 years; the sample was 54.7% female and 92.5% Caucasian. Nine intervention patients were extubated before protocol initiation. - Anxiety ratings did not differ between groups in intention-to-treat (p = 0.94) or per-protocol analyses (p = 0.30). - Intervention patients had a shorter mean duration of mechanical ventilation in the ITT analysis (50.8 vs. 68.7 hours; p = 0.02), but the per-protocol comparison showed no significant difference (56.4 vs. 68.7 hours; p = 0.23). - New delirium incidence was 10.2% in the intervention group and 8.5% in usual care; differences were not statistically significant by ITT (p = 0.65) or per-protocol analyses (p = 0.58). - Authors concluded that **self-administration** of sedative therapy was safe and produced similar outcomes to usual care, and they recommend further rigorous investigation of this patient-centered approach for anxiety self-management.
## Clinical Analysis & Structured Key Points
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Online ahead of print. # Randomized clinical trial of self-management of sedative therapy by mechanically ventilated patients [Linda L Chlan](https://pubmed.ncbi.nlm.nih.gov/?term=Chlan+LL&cauthor_id=42554300)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-1 "Associate Dean for Nursing Research, Division of Nursing Research, Department of Nursing, Professor of Nursing, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Mary Fran Tracy](https://pubmed.ncbi.nlm.nih.gov/?term=Tracy+MF&cauthor_id=42554300)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-2 "Professor, Assistant Dean for the PhD Program and Director of Graduate Studies, University of Minnesota, School of Nursing, 308 Harvard St. SE, Minneapolis, MN."), [Ognjen Gajic](https://pubmed.ncbi.nlm.nih.gov/?term=Gajic+O&cauthor_id=42554300)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-3 "Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Amos Lal](https://pubmed.ncbi.nlm.nih.gov/?term=Lal+A&cauthor_id=42554300)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-3 "Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Pamela Peterson](https://pubmed.ncbi.nlm.nih.gov/?term=Peterson+P&cauthor_id=42554300)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-4 "Division of Nursing Research, Department of Nursing, Mayo Clinic, 200 First St. SWRochester, MN."), [Jay Mandrekar](https://pubmed.ncbi.nlm.nih.gov/?term=Mandrekar+J&cauthor_id=42554300)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-5 "Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN."), [William S Harmsen](https://pubmed.ncbi.nlm.nih.gov/?term=Harmsen+WS&cauthor_id=42554300)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-5 "Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN."), [Erica Wittwer](https://pubmed.ncbi.nlm.nih.gov/?term=Wittwer+E&cauthor_id=42554300)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-6 "Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First St. SWRochester, MN."), [Craig R Weinert](https://pubmed.ncbi.nlm.nih.gov/?term=Weinert+CR&cauthor_id=42554300)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#full-view-affiliation-7 "Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota Medical School, Minneapolis, MN.") Affiliations Expand ### Affiliations * 1 Associate Dean for Nursing Research, Division of Nursing Research, Department of Nursing, Professor of Nursing, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN. * 2 Professor, Assistant Dean for the PhD Program and Director of Graduate Studies, University of Minnesota, School of Nursing, 308 Harvard St. SE, Minneapolis, MN. * 3 Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN. * 4 Division of Nursing Research, Department of Nursing, Mayo Clinic, 200 First St. SWRochester, MN. * 5 Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN. * 6 Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First St. SWRochester, MN. * 7 Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota Medical School, Minneapolis, MN. * PMID: **42554300** * DOI: [ 10.1093/annalsats/aaoag233 ](https://doi.org/10.1093/annalsats/aaoag233) Item in Clipboard # Randomized clinical trial of self-management of sedative therapy by mechanically ventilated patients Linda L Chlan et al. Ann Am Thorac Soc. 2026. Show details Display options Display options Format Abstract PubMed PMID Ann Am Thorac Soc Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Ann+Am+Thorac+Soc%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Ann+Am+Thorac+Soc%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42554300/) . 2026 Aug 5:aaoag233. doi: 10.1093/annalsats/aaoag233. Online ahead of print. ### Authors [Linda L Chlan](https://pubmed.ncbi.nlm.nih.gov/?term=Chlan+LL&cauthor_id=42554300)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-1 "Associate Dean for Nursing Research, Division of Nursing Research, Department of Nursing, Professor of Nursing, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Mary Fran Tracy](https://pubmed.ncbi.nlm.nih.gov/?term=Tracy+MF&cauthor_id=42554300)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-2 "Professor, Assistant Dean for the PhD Program and Director of Graduate Studies, University of Minnesota, School of Nursing, 308 Harvard St. SE, Minneapolis, MN."), [Ognjen Gajic](https://pubmed.ncbi.nlm.nih.gov/?term=Gajic+O&cauthor_id=42554300)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-3 "Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Amos Lal](https://pubmed.ncbi.nlm.nih.gov/?term=Lal+A&cauthor_id=42554300)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-3 "Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN."), [Pamela Peterson](https://pubmed.ncbi.nlm.nih.gov/?term=Peterson+P&cauthor_id=42554300)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-4 "Division of Nursing Research, Department of Nursing, Mayo Clinic, 200 First St. SWRochester, MN."), [Jay Mandrekar](https://pubmed.ncbi.nlm.nih.gov/?term=Mandrekar+J&cauthor_id=42554300)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-5 "Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN."), [William S Harmsen](https://pubmed.ncbi.nlm.nih.gov/?term=Harmsen+WS&cauthor_id=42554300)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-5 "Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN."), [Erica Wittwer](https://pubmed.ncbi.nlm.nih.gov/?term=Wittwer+E&cauthor_id=42554300)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-6 "Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First St. SWRochester, MN."), [Craig R Weinert](https://pubmed.ncbi.nlm.nih.gov/?term=Weinert+CR&cauthor_id=42554300)[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42554300/#short-view-affiliation-7 "Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota Medical School, Minneapolis, MN.") ### Affiliations * 1 Associate Dean for Nursing Research, Division of Nursing Research, Department of Nursing, Professor of Nursing, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN. * 2 Professor, Assistant Dean for the PhD Program and Director of Graduate Studies, University of Minnesota, School of Nursing, 308 Harvard St. SE, Minneapolis, MN. * 3 Department of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine and Science, Mayo Clinic, 200 First St. SW, Rochester, MN. * 4 Division of Nursing Research, Department of Nursing, Mayo Clinic, 200 First St. SWRochester, MN. * 5 Quantitative Health Sciences-Clinical Trials and Biostatistics, Mayo Clinic, 200 First St. SWRochester, MN. * 6 Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 200 First St. SWRochester, MN. * 7 Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota Medical School, Minneapolis, MN. * PMID: **42554300** * DOI: [ 10.1093/annalsats/aaoag233 ](https://doi.org/10.1093/annalsats/aaoag233) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Rationale:** Mechanically ventilated intensive care unit patients receive sedatives based on clinician observations of arousal and motor activity with potential for negative consequences and poor mitigation of symptoms. **Objectives:** To test the preliminary efficacy of patient self-managed sedative therapy compared to usual care of nurse-administered sedation on self-reported anxiety, duration of mechanical ventilation, and delirium incidence (CAM-ICU). **Methods:** A two-group, open-label, randomized, multicenter clinical trial in 5 Midwestern hospitals enrolled 161 patients receiving invasive mechanical ventilation who were willing and able to use a push-button device to self-administer sedation for up to 7 days. Patients were randomized 1:1 using center-stratified blocks to usual care (n = 81) or intervention (n = 80) with self-administered dexmedetomidine. Intervention patients were allowed 3 self-administered dexmedetomidine boluses per hour (0.25 mcg/kg) with 20-minute lock-outs. The initial basal infusion (0.2 mcg/kg/hr) was adjusted by nurses between 0.1-0.7 mcg/kg/hr based on patient-delivered boluses in the prior 2 hours. Analysis consisted of linear mixed-effects model for comparisons of anxiety ratings over time and duration of mechanical ventilation. Incidence of delirium was analyzed using generalized estimating equations. **Measurement and main results:** Sample characteristics had a female (54.7%) and Caucasian preponderance (92.5%) with a median age of 62 years on protocol for a median of 88 hours. Nine intervention patients were extubated prior to protocol initiation. Patient self-reported three times daily anxiety ratings with a visual analog scale (VAS) ranged from 0-100 over time but were not significantly different between groups in either an intention-to-treat (ITT) or per protocol (PP) analysis (p = 0.94, p = 0.30 respectively). While intervention patients had shorter duration of MV [(mean 50.8(52.8) vs. usual care 68.7(58.2) hours), p = 0.02 ITT], PP analysis resulted in no difference between groups (mean 56.4 (53.0) vs. 68.7(58.2), p = 0.23). 10.2% of intervention patients developed new incidence of delirium vs. 8.5% of usual care which was not significantly different between groups by either ITT (p = 0.65) or PP analyses (p = 0.58). **Conclusions:** Intervention patients had similar outcomes compared to usual care patients. Self-administration of sedative therapy is a safe, novel patient-centered intervention warranting further rigorous investigation for anxiety self-management. **Keywords:** anxiety; delirium; intensive care unit; invasive mechanical ventilation; sedation. © The Author(s) 2026. Published by Oxford University Press on behalf of the American Thoracic Society. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Similar articles * [ Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/33115543/) Emadi A, Chua JV, Talwani R, Bentzen SM, Baddley J.Emadi A, et al.Trials. 2020 Oct 28;21(1):897. doi: 10.1186/s13063-020-04819-9.Trials. 2020.PMID: 33115543Free PMC article. * [ Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. ](https://pubmed.ncbi.nlm.nih.gov/25602358/) Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network.Curley MA, et al.JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.JAMA. 2015.PMID: 25602358Free PMC article.Clinical Trial. * [ Co-ordinated multidisciplinary intervention to reduce time to successful extubation for children on mechanical ventilation: the SANDWICH cluster stepped-wedge RCT. ](https://pubmed.ncbi.nlm.nih.gov/35289741/) Blackwood B, Morris KP, Jordan J, McIlmurray L, Agus A, Boyle R, Clarke M, Easter C, Feltbower RG, Hemming K, Macrae D, McDowell C, Murray M, Parslow R, Peters MJ, Phair G, Tume LN, Walsh TS, McAuley DF.Blackwood B, et al.Health Technol Assess. 2022 Mar;26(18):1-114. doi: 10.3310/TCFX3817.Health Technol Assess. 2022.PMID: 35289741Clinical Trial. * [ Protocol-directed sedation versus non-protocol-directed sedation to reduce duration of mechanical ventilation in mechanically ventilated intensive care patients. ](https://pubmed.ncbi.nlm.nih.gov/25562750/) Aitken LM, Bucknall T, Kent B, Mitchell M, Burmeister E, Keogh SJ.Aitken LM, et al.Cochrane Database Syst Rev. 2015 Jan 7;1:CD009771. doi: 10.1002/14651858.CD009771.pub2.Cochrane Database Syst Rev. 2015.Update in: [Cochrane Database Syst Rev. 2018 Nov 12;11:CD009771. doi: 10.1002/14651858.CD009771.pub3.](https://pubmed.ncbi.nlm.nih.gov/30480753/)PMID: 25562750Updated. * [ Protocol-directed sedation versus non-protocol-directed sedation in mechanically ventilated intensive care adults and children. ](https://pubmed.ncbi.nlm.nih.gov/30480753/) Aitken LM, Bucknall T, Kent B, Mitchell M, Burmeister E, Keogh SJ.Aitken LM, et al.Cochrane Database Syst Rev. 2018 Nov 12;11(11):CD009771. doi: 10.1002/14651858.CD009771.pub3.Cochrane Database Syst Rev. 2018.PMID: 30480753Free PMC article. 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