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Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100735
Recruitment Status : Withdrawn (Difficulty in with enrollment of patient)
First Posted : April 1, 2014
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Beatrice Adams, 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.

Condition or disease Intervention/treatment Phase
Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU Other: Sedation protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: Sedation protocol
Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU.
Other: Sedation protocol
Nursing driven sedation protocol
Other Name: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU

Active Comparator: Standard of care
Current practices
Other: Sedation protocol
Nursing driven sedation protocol
Other Name: The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU




Primary Outcome Measures :
  1. Days on mechanical ventilation [ Time Frame: Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days ]

Secondary Outcome Measures :
  1. ICU Length of stay [ Time Frame: Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days ]
  2. 28 day mortality [ Time Frame: Participants will be followed for 28 days from enrollment into the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100735


Locations
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United States, Florida
Beatrice Adams
Riverview, Florida, United States, 33569
Sponsors and Collaborators
Tampa General Hospital
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Responsible Party: Beatrice Adams, Pharmacotherapy Specialist, Tampa General Hospital
ClinicalTrials.gov Identifier: NCT02100735    
Other Study ID Numbers: Pro00016830
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beatrice Adams, Tampa General Hospital:
sedatives
analgesics
protocol
mechanical ventilation
analgosedation