NCT01370278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 16, 2011

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

12.2 years

First QC Date

June 8, 2011

Last Update Submit

August 24, 2023

Conditions

Lung NeoplasmsRespiratory FailurePneumoniaAcute Coronary SyndromesUnstable AnginaMyocardial InfarctionCardiac ArrhythmiaThromboembolic Disease

Keywords

Central airway obstructionlumen obstructionSodium bicarbonateBaking sodaNormal salineSalt waterAirway stentsBronchoscopymucus obstruction

Outcome Measures

Primary Outcomes (1)

  • Percentage of obstruction resolution as Good or Excellent

    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.

    Baseline to 7 days

Study Arms (2)

Normal Saline

ACTIVE COMPARATOR

Normal saline sprayed into stent/airway tubes then suctioned out through bronchoscope.

Other: Normal Saline

Sodium Bicarbonate

ACTIVE COMPARATOR

Sodium bicarbonate sprayed into stent/airway tubes then suctioned out through bronchoscope.

Other: Sodium Bicarbonate

Interventions

Normal SalineOTHER

Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope.

Also known as: Salt water
Normal Saline
Sodium BicarbonateOTHER

4.2% bicarbonate solution mixed with equal volume of sterile water administered into stent/airway tubes under direct visualization via the bronchoscope.

Also known as: Baking soda
Sodium Bicarbonate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with history of allergy or adverse reactions to sodium bicarbonate or normal saline.
  • Patients refusing to sign informed written consent for participation in research.
  • Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment.
  • Previously enrolled patients who completed this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsRespiratory InsufficiencyPneumoniaAcute Coronary SyndromeAngina, UnstableMyocardial InfarctionArrhythmias, CardiacThromboembolism

Interventions

Saline SolutionFluoridationSodium Bicarbonate

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Tract InfectionsInfectionsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosisEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPreventive DentistryDentistryPublic Health DentistryEnvironment and Public HealthBicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Carlos A. Jimenez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

June 16, 2011

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

US(1)