Weighted Blankets for Agitation in Adults in the Intensive Care Unit
NCT07920497, Not applicable, Active not recruiting, Anmed Health
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Weighted Blankets for Agitation in Adults in the Intensive Care Unit | ClinicalTrials.gov |
| NCT number | NCT07920497 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Anmed Health | ClinicalTrials.gov |
| Conditions | Psychomotor Agitation, Critical Illness | ClinicalTrials.gov |
| Interventions | Weighted-blanket, Attention Control: Standard Blanket and Usual Comfort Measures | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Richmond Agitation-Sedation Scale (RASS) Score | Baseline and 1 hour | Change in Richmond Agitation-Sedation Scale (RASS) score from immediately before the study session to 1 hour after initiation of the weighted blanket or attention-control session. Change is calculated as the 1-hour score minus the baseline score and compared between groups. RASS scores range from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm. Positive scores indicate increasing agitation, while negative scores indicate increasing sedation. A negative change indicates a shift toward less agitation or greater sedation and does not necessarily indicate clinical improvement. | ClinicalTrials.gov |
| Secondary | Number of PRN Anxiolytic or Sedative Administrations | Baseline and 2 hours | Number of as-needed (PRN) anxiolytic or sedative medication administrations recorded in the medication administration record during the 2 hours following the start of each weighted blanket or attention-control session. Medication name, dose, route, and administration time will be recorded. | ClinicalTrials.gov |
| Secondary | Change in Heart Rate | Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points. | Change in heart rate, measured in beats per minute, from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Systolic Blood Pressure | Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points. | Change in systolic blood pressure, measured in millimeters of mercury (mmHg), from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups. | ClinicalTrials.gov |
| Secondary | Change in Diastolic Blood Pressure | Baseline and 30 minutes, 1 hour, and 2 hours after initiation of each study session, when the session continues to those time points. | Change in diastolic blood pressure, measured in millimeters of mercury (mmHg), from immediately before session initiation to each scheduled assessment. Change will be calculated as the follow-up value minus the baseline value and compared between groups. | ClinicalTrials.gov |
| Secondary | ICU Length of Stay | From ICU admission through ICU discharge, up to 30 days. | Number of days from ICU admission until ICU discharge. | ClinicalTrials.gov |
| Secondary | Duration of Mechanical Ventilation | From initiation of invasive mechanical ventilation until discontinuation of invasive mechanical ventilation, up to 30 days. | Total number of days the participant receives invasive mechanical ventilation during the ICU stay. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)