Mucus ObstructionNCT00131521
Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit
A study testing mucomyst and sodium chloride (saline) in people with Mucus Obstruction and Intubation, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucus Obstruction, Intubation
- What is being tested?
- mucomyst and sodium chloride (saline)
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient anticipated to be extubated within 24 hours following STICU admission
- Hypersensitivity to acetylcysteine.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Mucus Obstruction, Intubation
- Being tested
- mucomyst, sodium chloride (saline)
- Keywords
- mucus obstruction, ventilator management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucomystDrug
sodium chloride (saline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of pulmonary mucus obstruction
Secondary outcomes (1)
days of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJan 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucus ObstructionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- John G. Myers, M.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131521
- Sponsor's protocol ID
- 034-1502-320
- Status last verified
- Jun 2009
- First submitted
- 17 Aug 2005
- Last updated
- 23 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00131521
- Acronym / sponsor ID
- 034-1502-320
- Conditions
- Mucus Obstruction, Intubation
- Keywords
- mucus obstruction, ventilator management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient anticipated to be extubated within 24 hours following STICU admission
- Hypersensitivity to acetylcysteine.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mucomyst | Drug | – |
| sodium chloride (saline) | Drug | – |
Primary outcome
prevention of pulmonary mucus obstruction
1 secondary outcome
days of mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
Related trials for Mucus Obstruction
RecruitingObservational study
Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G. Myers, M.D. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mucomyst and sodium chloride (saline) in people with Mucus Obstruction and Intubation, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of pulmonary mucus obstruction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.