Sepsis Clinical Trial
Official title:
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
Verified date | March 2022 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.
Status | Completed |
Enrollment | 58 |
Est. completion date | December 28, 2021 |
Est. primary completion date | December 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years old - Requiring ICU care - Requiring wrist or mitt restraints and has active physician order - Expected ICU stay =2 days after enrollment - Responsive to verbal stimulus Exclusion Criteria: - Bilateral upper extremity impairments (e.g. arm injuries) or problems (e.g. severe skin breakdown) that prevent use of novel restraint device. Normal use of one arm (e.g. unilateral upper extremity amputation) is acceptable. - Very limited mobility of bilateral upper extremities prior to admission (e.g. bilateral frozen shoulders). Normal use of one arm is acceptable. - Pre-existing severe neuromuscular condition inhibiting or axacerbating upper extremity movement (e.g. Guillain-Barre, severe tremor, myoclonus) - Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) - Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment - Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment - Incarcerated - Pregnant - Attending physician declines patient enrollment - LAR unavailable to consent (and patient is unable to consent) - Patient or LAR decline consent |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Vermont | Burlington | Vermont |
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of Vermont | Healthy Design, LLC, Johns Hopkins University, University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction with novel restraint (nurses, family, physicians, and patients when able) | Satisfaction and acceptability will be assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) survey. The QUEST 2.0 is a valid, reliable, and widely used 12-question survey assessing satisfaction with technological devices. It is scored from 1-5, with >3.26 considered high satisfaction. The QUEST 2.0 has 2 subscales (satisfaction with device and with services). Satisfaction with the Exersides restraint will be assessed using the device subscale, which has good test-retest stability (ICC 0.82). | Up to 6 days | |
Other | Acceptability of novel restraint (nurses, family, physicians, and patients when able) | Acceptability will be assessed with semi-structured interviews using open-ended questions | Up to 6 days | |
Primary | Mobility assessed by actigraphy | Upper extremity mobility will be evaluated by actigraphy. The Philips Respironics Spectrum PlusĀ® actigraph is a commercially-available actigraphy device weighing 16 grams. It contains a battery-powered activity monitor and uses a highly sensitive accelerometer to monitor the occurrence and degree of motion. Only patients who wear both the novel restraint and traditional soft wrist restraints for at least 4 hours each will be included in the primary analysis. | Up to 6 days | |
Secondary | Sedation/Agitation | Agitation will be measured via RASS (Richmond Agitation Sedation Scale) score. RASS is a validated and reliable ordinal measure of sedation/agitation status in the ICU ranging from -5 (extremely sedated, no response to voice or physical stimulation) to +4 (extremely agitated, violent, combative). | Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6 | |
Secondary | Delirium | Delirium will be measured via CAM-ICU (Confusion Assessment Method for the ICU). The CAM-ICU score is a validated and reliable binary measure of delirium status in the ICU. A "yes" score means delirium is present, and a "no score means delirium is absent. | Baseline, every 4 hours days 1-2, twice daily days 3-6 | |
Secondary | Average cumulative dose of sedative medications | Cumulative use of sedative medications over the 6 day study period | Up to 6 days | |
Secondary | Average cumulative dose of analgesic medications | Cumulative use of analgesics over the 6 day study period | Up to 6 days | |
Secondary | Average cumulative dose of antipsychotic medications | Cumulative use of antipsychotics over the 6 day study period | Up to 6 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 |