Clearance Of Mucus In Stents (COMIS)

Tracking Information
First Submitted Date ICMJE	June 8, 2011
First Posted Date ICMJE	June 9, 2011
Last Update Posted Date	March 2, 2018
Actual Study Start Date ICMJE	June 16, 2011
Estimated Primary Completion Date	June 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 8, 2011)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01370278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Clearance Of Mucus In Stents (COMIS)
Official Title ICMJE	Clearance Of Mucus In Stents (COMIS)
Brief Summary	The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.
Detailed Description	Study Agents: Sodium bicarbonate is also called baking soda. In this study it will be mixed with water. Normal saline is a salt water solution. Study Groups: If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. The study doctor will use either sodium bicarbonate or normal saline during your bronchoscopy to clear mucus from your stent: If you are in Group 1, the study doctor will use sodium bicarbonate. The amount of sodium bicarbonate in the solution will be the same for all patients in Group 1.; If you are in Group 2, the study doctor will use normal saline. You will have an equal chance of being assigned to either group. Neither you nor the study staff can choose the group you will be in, and neither you nor your doctor will know if you are receiving sodium bicarbonate or normal saline. However, if needed for your safety, the study staff will be able to find out what you are receiving. If you have more than 1 stent, only 1 of your stents will be checked for clearance of mucus in this study. However, all stents will be cleared of mucus if needed. As part of your standard of care, you will have photographs and videos taken before and after your bronchoscopy. You will sign a separate consent form for your bronchoscopy. Your complete medical history will also be recorded. For the bronchoscopy, you will be given drugs to help you relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your airway tubes. If you are in Group 1, a small amount of sodium bicarbonate will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope. If you are in Group 2, a small amount of normal saline will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope. Next, 3 study doctors will check how well the mucus in your stent was cleared. If the study doctors think not enough mucus has been cleared from your stent, you will "crossover" into the other study group and receive the other agent to clear your mucus. Length of Study: Your participation on the study will be over after you have completed the follow-up visits. Follow-Up: At about 7 days, and then again 30 days after your bronchoscopy, you will come to the clinic for a follow-up visit. The following procedures will be performed: You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).; You will also be asked about any side effects you may be having. This is an investigational study. Normal saline and sodium bicarbonate are agents used in bronchoscopies performed in patients with airway stents as standard of care. The comparison of sodium bicarbonate to normal saline to clear mucus from airway stents is considered investigational. Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Diagnostic
Condition ICMJE	Lung Neoplasms; Respiratory Failure; Pneumonia; Acute Coronary Syndromes; Unstable Angina; Myocardial Infarction; Cardiac Arrhythmia; Thromboembolic Disease
Intervention ICMJE	Other: Normal Saline Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope. Other Name: Salt water; 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
Study Arms	Active Comparator: Normal Saline Normal saline sprayed into stent/airway tubes then suctioned out through bronchoscope. Intervention: Other: Normal Saline; Active Comparator: Sodium Bicarbonate Sodium bicarbonate sprayed into stent/airway tubes then suctioned out through bronchoscope. Intervention: Other: Sodium Bicarbonate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: February 28, 2018)	43
Original Estimated Enrollment ICMJE; (submitted: June 8, 2011)	40
Estimated Study Completion Date	June 2020
Estimated Primary Completion Date	June 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Adult patients (>/= 18 years) with airway stents undergoing bronchoscopy.; Patients previously enrolled, but excluded as no stent lumen obstruction from mucus retention identified at earlier enrollment (hence excluded at that enrollment) . Exclusion Criteria: Patients with history of allergy or adverse reactions to sodium bicarbonate or normal saline.; Patients refusing to sign informed written consent for participation in research.; Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment.; Previously enrolled patients who completed this protocol.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01370278
Other Study ID Numbers ICMJE	2010-0990; NCI-2011-01119 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
PRS Account	M.D. Anderson Cancer Center
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP