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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
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01370278    
Other Study ID Numbers: 2010-0990
NCI-2011-01119 ( Registry Identifier: NCI CTRP )
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Central airway obstruction
lumen obstruction
Sodium bicarbonate
Baking soda
Normal saline
Salt water
Airway stents
Bronchoscopy
mucus obstruction
Additional relevant MeSH terms:
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Lung Neoplasms
Pneumonia
Respiratory Insufficiency
Myocardial Infarction
Acute Coronary Syndrome
Arrhythmias, Cardiac
Angina, Unstable
Thromboembolism
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Embolism and Thrombosis