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NCT00131521 Clinical Trial

Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit

Intubation Clinical Trial

Official title:
Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit: A Randomized, Double Blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00131521
Other study ID # 034-1502-320
Secondary ID
Status Completed
Phase N/A
First received August 17, 2005
Last updated June 20, 2009
Start date January 2005
Est. completion date December 2007

Study information
Verified date June 2009
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Intubated and admitted to the Surgical Trauma Intensive Care Unit (STICU)

- Subjects must be eligible to start treatment within 24 hours of their initial intubation

Exclusion Criteria:

- Patient anticipated to be extubated within 24 hours following STICU admission

- Hypersensitivity to acetylcysteine.

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• mucomyst

• sodium chloride (saline)

Locations
Country Name City State
United States Univesity Hospital San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevention of pulmonary mucus obstruction
Secondary days of mechanical ventilation
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