This phase II trial studies sodium bicarbonate in clearing mucus blockage in patients with airway stents. Sodium bicarbonate may help clear blockages in patients with airway stents. It is not yet known whether sodium bicarbonate is more effective than normal saline in clearing mucus blockage in patients with airway stents.
Additional locations may be listed on ClinicalTrials.gov for NCT01370278.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To compare the effect of sodium bicarbonate versus (vs) normal saline administered bronchoscopically to clear mucus impaction in airway stents.
SECONDARY OBJECTIVES:
I. Respiratory failure.
II. Acute coronary syndromes (unstable angina, myocardial infarction).
III. Cardiac arrhythmia requiring short term therapy.
IV. Pneumonia defined as at least three of the following parameters: infiltrate on chest roentgenograms for more than 48 hours, temperature greater than 38 centigrade or less than 35 centigrade, purulent sputum, leukocytosis greater than 10,000/mm^3 or white blood cell count of less than 3,000/mm^3, and pathogenic microorganism from endotracheal aspirate.
V. Lobar atelectasis on imaging studies.
VI. Thromboembolic disease (confirmed with diagnostic imaging).
VII. New or worsening airway hyper reactivity requiring new or additional medical interventions.
VIII. Death.
IX. Reobstruction of stent by mucus at 30 days.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo bronchoscopy and receive sodium bicarbonate oral spray into the stent/airway tubes and then suctioned out through the bronchoscope.
ARM II: Patients undergo bronchoscopy and receive normal saline oral spray into the stent/airway tubes and then suctioned out through the bronchoscope.
Patients with no response, poor or fair response to the instilled agent may cross over to receive the other agent.
After completion of study treatment, patients are followed up at 7 days and at 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorCarlos A. Jimenez