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Clearance Of Mucus In Stents

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ClinicalTrials.gov Identifier: NCT01370278
Recruitment Status : Recruiting
First Posted : June 9, 2011
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Lung Neoplasms Respiratory Failure Pneumonia Acute Coronary Syndromes Unstable Angina Myocardial Infarction Cardiac Arrhythmia Thromboembolic Disease Other: Normal Saline Other: Sodium Bicarbonate

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Contacts and Locations

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


Contacts
Contact: Carlos A. Jimenez, MD 713-792-6238

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01370278     History of Changes
Other Study ID Numbers: 2010-0990
NCI-2011-01119 ( Registry Identifier: NCI CTRP )
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

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:
Infarction
Myocardial Infarction
Pneumonia
Acute Coronary Syndrome
Respiratory Insufficiency
Lung Neoplasms
Angina, Unstable
Arrhythmias, Cardiac
Thromboembolism
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
Nervous System Diseases
Signs and Symptoms