Status:
ENROLLING_BY_INVITATION
A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Respiratory Failure
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate a specific approach to patient care called a time-limited trial (TLT). This approach is sometimes used for people who develop critical illness and are cared...
Detailed Description
This is a multi-site observational study that will investigate the time-limited trial approach to care for patients with critical illness, which is a trial of life support with milestones and a timeli...
Eligibility Criteria
Inclusion
- Participants
- Adult (age ≥ 18 years)
- Acute respiratory failure:
- Hypoxemic (low level of oxygen in the blood) or
- Hypercapnic (high level of carbon dioxide in the blood)
- Receiving invasive mechanical ventilation (patient needs a breathing machine to help them breathe)
- Surrogates
- The main person/s (primary surrogate/s, also known as legally authorized representative/s) who are making medical decisions on behalf of an eligible patient
- Will be identified by the treating ICU team according to established legal and ethical standards
- ICU Team Members
- A member of the interprofessional hospital staff that is caring for an eligible patient
- Team members may include advanced practice providers (nurse practitioners/ physicians assistants), case managers, chaplains, dietitians, nurses, pharmacists, physical and occupational therapists, physicians (attending/fellow/resident), respiratory therapists, and social workers.
Exclusion
- Participants
- Participant or their legally authorized representative declines participation or opts-out of data collection
- Surrogates
- Cannot complete surveys and interviews in English or Spanish
- Declines participation
- ICU Team Members
- Opts out of study participation
Key Trial Info
Start Date :
January 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
7818 Patients enrolled
Trial Details
Trial ID
NCT06042621
Start Date
January 17 2024
End Date
March 1 2028
Last Update
November 25 2025
Active Locations (5)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
4
UnityPoint Health - Meriter Hospital
Madison, Wisconsin, United States, 53715