Clearance Of Mucus In Stents

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 16, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Clearance Of Mucus In Stents (COMIS)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370278

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

Locations
United States, Texas
UT 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 UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01370278     History of Changes
Other Study ID Numbers: 2010-0990, NCI-2011-01119
Study First Received: June 8, 2011
Last Updated: April 16, 2014
Health Authority: United States: Institutional Review Board

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
Acute Coronary Syndrome
Respiratory Insufficiency
Lung Neoplasms
Angina, Unstable
Arrhythmias, Cardiac
Thromboembolism
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on October 01, 2014