Clearance Of Mucus In Stents

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01370278
First received: June 8, 2011
Last updated: October 6, 2014
Last verified: October 2014

June 8, 2011
October 6, 2014
June 2011
June 2016   (final data collection date for primary outcome measure)
Percentage of obstruction resolution as Good or Excellent [ Time Frame: Baseline to 7 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01370278 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clearance Of Mucus In Stents
Clearance Of Mucus In Stents (COMIS)

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.

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.

Study Procedure:

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
  • Lung Neoplasms
  • Respiratory Failure
  • Pneumonia
  • Acute Coronary Syndromes
  • Unstable Angina
  • Myocardial Infarction
  • Cardiac Arrhythmia
  • Thromboembolic Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult patients (>/= 18 years) with airway stents undergoing bronchoscopy.
  2. Patients previously enrolled, but excluded as no stent lumen obstruction from mucus retention identified at earlier enrollment (hence excluded at that enrollment) .

Exclusion Criteria:

  1. Patients with history of allergy or adverse reactions to sodium bicarbonate or normal saline.
  2. Patients refusing to sign informed written consent for participation in research.
  3. Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment.
  4. Previously enrolled patients who completed this protocol.
Both
18 Years and older
Yes
Contact: Carlos A. Jimenez, MD 713-792-6238
United States
 
NCT01370278
2010-0990, NCI-2011-01119
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP