Clearance Of Mucus In Stents (COMIS)
|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: NCT01370278|
Recruitment Status : Active, not recruiting
First Posted : June 9, 2011
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasms Respiratory Failure Pneumonia Acute Coronary Syndromes Unstable Angina Myocardial Infarction Cardiac Arrhythmia Thromboembolic Disease||Other: Normal Saline Other: Sodium Bicarbonate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clearance Of Mucus In Stents (COMIS)|
|Actual Study Start Date :||June 16, 2011|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Normal Saline
Normal saline sprayed into stent/airway tubes then suctioned out through bronchoscope.
Other: Normal Saline
Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope.
Other Name: Salt water
Active Comparator: Sodium Bicarbonate
Sodium bicarbonate sprayed into stent/airway tubes then suctioned out through bronchoscope.
Other: Sodium Bicarbonate
4.2% bicarbonate solution mixed with equal volume of sterile water administered into stent/airway tubes under direct visualization via the bronchoscope.
Other Name: Baking soda
- Percentage of obstruction resolution as Good or Excellent [ Time Frame: Baseline to 7 days ]Response/efficacy of sodium bicarbonate versus normal saline in airway stents graded using scale. Percentage of obstruction resolution (relative to initial stent lumen obstruction by mucus): Good response 51-75% clearance; and Excellent 76 - 100% clearance. The Mantel-Haenszel chi-square test stratified by degree of lumen obstruction at study enrollment used to compare response (good or excellent obstruction resolution) rates between treatment arms.
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): NCT01370278
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Carlos A. Jimenez, MD||M.D. Anderson Cancer Center|