Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU Clinical Trial
Official title:
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients
| Verified date | October 2020 |
| Source | Tampa General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate how the investigators provide sedation (medicine that make you sleepy) in the investigators intensive care unit (ICU). This study will look at a new way of using sedation in the ICU to see what effect it has on patients and if it decreases the amount of time spent on mechanical ventilation (machine that breathes for you), and in the ICU.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 2021 |
| Est. primary completion date | April 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | Inclusion Criteria: - Patients 18 years of age and older - Patients expected to require mechanical ventilation for greater than 48 hrs Exclusion Criteria: - Need for continuous neuromuscular blockade - Severe chronic neurocognitive dysfunction - Tracheostomy at the time of study enrollment - Alcohol withdrawal risk or symptoms - Drug overdose - Chronic use of narcotics - Active seizures |
| Country | Name | City | State |
|---|---|---|---|
| United States | Beatrice Adams | Riverview | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Tampa General Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Days on mechanical ventilation | Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days | ||
| Secondary | ICU Length of stay | Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days | ||
| Secondary | 28 day mortality | Participants will be followed for 28 days from enrollment into the study |