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NCT03886454 · ClinicalTrials.gov registry record
Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
A clinical trial, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 33
- Enrollment target
NCT03886454: Completed study, sponsored by Tufts Medical Center.
NCT03886454 is a clinical trial that has completed, run by Tufts Medical Center. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03886454 has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 33 participants
- Enrollment target
Study Summary
This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. To achieve this, investigators use a physiologic monitoring device (NOX T3, K082113) that has been FDA approved for the screening and diagnosis of sleep disordered breathing \[1\]. The results from this pilot study will be used to assess the feasibility of a prospective study utilizing continuous external negative pressure (Pneuway). This negative pressure is applied through a neck mask to alleviate upper airway collapsibility and can potentially decrease the number of apneas during bronchoscopy under conscious sedation \[2\].
Primary Outcome
Obstructive apnea are defined as more than 90% cessation of air-flow that lasts for at least 10 seconds, despite the presence of respiratory and abdominal muscle effort. Obstructive hypopnea is when more than 30% cessation of air-flow occurs that lasts for at least 10 seconds, and is associated with oxygen desaturation of at least 3% from baseline. Central apnea is when cessation of air-flow occurs secondary to absent respiratory and abdominal muscle effort, that lasts for at least 10 seconds.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2019-07-01 |
What the finished NCT03886454 record still lists
NCT03886454 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03886454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03886454 about?
NCT03886454 is a clinical study titled "Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study". This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. To achieve this, ...
What is the current status of trial NCT03886454?
This trial is currently completed. The enrollment target is 33 participants. The study started on 2017-06-19. Estimated completion is 2019-07-01.
Who is sponsoring clinical trial NCT03886454?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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