Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

Not Applicable

Withdrawn

• Conditions: Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU
• Interventions: Other: Sedation protocol

• Registration Number: NCT02100735
• Lead Sponsor: Tampa General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Study Start: 2019-09-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Sedation protocol	Current practices
Sedation protocol	Sedation protocol	Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ICU Length of stay	Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days
28 day mortality	Participants will be followed for 28 days from enrollment into the study

Trial Locations

Locations (1)

Beatrice Adams; 🇺🇸 Riverview, Florida, United States