Sedation Versus No Sedation in a Spontaneous Breathing Trial

NCT00366353 | Terminated

• 1 other identifier: 05-10
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

An important part of how we decide when a patient is ready to have their breathing tube removed is to have a person breathe without any machine breaths while the breathing tube is still in place. We call this a spontaneous breathing trial. Commonly, while patients have the breathing tube, they are given medications to keep them sedated and comfortable so breathing does not bother them. These medicines are often stopped before the spontaneous breathing trial so they can be more awake for the test. There are signs the doctors look for during the spontaneous breathing trial that suggest the patient might not be ready for the breathing trial to come out. Signs like fast breathing, small breaths, a fast heart rate, or looking more anxious than usual may mean that the patient is not ready to come off the ventilator. However, if someone has been given sedation medicines the entire time they have had a breathing tube and are then woken up, they may naturally get very anxious. They may show the same signs as someone who is failing their breathing test, but in their case these signs are only because they are anxious.Doctors may mistake these signs as failing the breathing test and may not pull the breathing tube out even though the patient is really ready for it to come out. We wish to try and find out if patients do better during their spontaneous breathing trials if they are continued on some sedative medicines to treat anxiety or if they do better if the medicines are stopped before the test.

Conditions

Respiratory Insufficiency

Keywords

Mechanical Ventilation; Spontaneous Breathing Trial; Sedation

Outcome Measures

Primary Outcomes (1)

• Changes in cardiopulmonary variables and RASS during the SBT

  2hrs unless directed by ICU attending physician

Secondary Outcomes (1)

• Time from randomization to the first SBT

  Time of first SBT

Study Arms (2)

1

OTHER

Sedation suring a spontaneous breathing trial.

Other: Sedation during SBT

2

OTHER

No sedation during spontaneous breathing trial

Other: No sedation

Interventions

Sedation during SBT OTHER

1

No sedation OTHER

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age 18 or older
• Intubation time greater than or equal to 24 hours
• Patient is sedated at the time the MICU writes the order for the SBT. A RASS score of less than -2 will be considered sedated

You may not qualify if:

• Acute brain injury
• Pregnancy
• Wards of the state

Sponsors & Collaborators

• Memorial Medical Center: lead

Study Sites (1)

Memorial Medical Center

Johnstown, Pennsylvania, 15905, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Jack L DePriest

  Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 21, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

US (1)