Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
Completed
Conditions studied: Conscious Sedation, Bronchoscopy
In brief
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 \[2\].
Key facts
- Study ID
- NCT03886454
- Run by
- Tufts Medical Center
- People needed
- 33
- Starts
- 2017-06-19
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2019-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with respiratory pathology that require bronchoscopy for further diagnostic evaluation, as part of standard of care
- Age of 18 years or older.
- Our study does not include the recruitment of vulnerable populations such as cognitively impaired adults, pregnant women, pregnant minors, minors, wards of the state, non-viable neonates, neonates of uncertain viability and prisoners.
You may not qualify if…
- Oxygen requirement of more than 4 Liter prior to procedure.
- Intubation or any airway support.
- Presence of severe cardiopulmonary or neurologic disease as determined by the investigator.
- Nasal congestion/obstruction preventing proper placement and monitoring of air flow
- Inability to provide informed consent.
- All vulnerable population mentioned above.
Where it is running
- Tufts Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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