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NCT03886454

Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study

Completed Last updated 28 August 2019
What this trial tests

trial in Conscious Sedation in 33 participants. Completed in 1 July 2019.

Timeline
19 June 2017
Primary endpoint
1 June 2019
1 July 2019

Quick facts

Lead sponsorTufts Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date19 June 2017
Primary completion1 June 2019
Estimated completion1 July 2019
Sites1 location across United States

Conditions studied

Sponsor

Tufts Medical Center

Who can join

18 and older, any sex, with Conscious Sedation or Bronchoscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 \[2\].

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Conscious Sedation

Currently open trials in the same condition.

Other Tufts Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing