PEEP Mask for Tracheobronchomalacia-Induced Cough

NCT04169282 | Completed Results FDA Device

• 1 other identifier: Pro00102498
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if an expiratory resistance device that delivers non-invasive positive expiratory pressure (nPEP) will reduce or stop coughing, reduce airway resistance and improve quality of life in patients with tracheobronchomalacia (TBM) who are not candidates for tracheal stenting.

Conditions

Tracheobronchomalacia

Keywords

tracheobronchomalacia; TBM; cough

Outcome Measures

Primary Outcomes (3)

• Change in Cough Severity as Measured by the Cough Visual Analog Scale (VAS)

  The primary objective is to determine if use of the nPEP device will change cough severity. Responses to the Cough VAS range from 0-100 mm, with higher scores corresponding to worse outcomes.

  Baseline, two weeks

• Change in Quality of Life as Measured by the Cough-Specific Quality-of-Life Questionnaire (CQLQ)

  The CQLQ score ranges from 28 to 112, with higher scores corresponding to worse outcomes.

  Baseline, two weeks

• Change in Quality of Life as Measured by the Leicester Cough Questionnaire (LCQ)

  The LCQ score ranges from 19 to 133, with lower scores corresponding to worse outcomes.

  Baseline, two weeks

Secondary Outcomes (1)

• Proximal Airway Reactance at 5 Hz (X5) as Assessed by Impulse Oscillometry

  Baseline, two weeks

Study Arms (1)

nPEP Recipients

EXPERIMENTAL

Single-patient, adjustable expiratory resistance device that provides positive pressure (5 to 20 cm H2O) during expiration

Device: nPEP (non-invasive positive expiratory pressure) mask

Interventions

nPEP (non-invasive positive expiratory pressure) mask DEVICE

Positive end expiratory pressure (PEEP) mask

nPEP Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Visualization of ≥50% collapse of the trachea or mainstem bronchus on CT scan or bronchoscopy
• No upper or lower respiratory infection within 4 weeks
• Having capacity to provide legal written informed consent

You may not qualify if:

• History of tracheobronchoplasty or chronic tracheal stenting
• Current tracheostomy
• History of external chest trauma
• History of:
• Active treatment for Lung cancer
• Lung transplantation
• Unstable congestive heart failure
• History of spontaneous pneumothorax
• Other medical conditions that interfere with participation in the study
• Pregnant women

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Tracheobronchomalacia; Cough

Interventions

Masks

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Loretta Que, MD
• Organization: Duke University

loretta.que@duke.edu

919-681-8551

Study Officials

• Loretta G Que, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: August 30, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)