Observing Changes in Ventilation Pattern During Procedural Sedation

NCT ID: NCT02825433

Last Updated: 2016-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-03-31

Brief Summary

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The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients receiving procedural sedation during endoscopy procedures in order to observe what changes commonly occur.

Detailed Description

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The literature does not currently describe which ventilation changes a clinician should watch for to keep a patient safe during procedural sedation provided by fentanyl and propofol. This observational study aimed to record the breath-by-breath respiratory rate, tidal volume and end-tidal CO2 for each patient during procedural sedation for each endoscopy procedure. Data analysis offline will aim to identify any patterns in ventilation which may precede apnea or blood oxygen desaturation. The patterns in ventilation preceding apnea or blood oxygen saturation will be compared and contrasted with the patterns of ventilation during normal ventilation periods.

Conditions

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Pulmonary Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving procedural sedation

The investigators collected ventilation data for each breath (respiratory rate, tidal volume, and end-tidal CO2) for all patients receiving procedural sedation for endoscopy.

No intervention, only ventilation monitoring

Intervention Type OTHER

Interventions

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No intervention, only ventilation monitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* (i) ASA I, II, or III
* (ii) patients older than eighteen
* (iii) English speaking
* (iv) undergoing a colonoscopy procedure and receiving procedural sedation

Exclusion Criteria

* (i) inability/refusal of subject to provide informed consent
* (iii) patients with severe medical conditions that in the view of the acting physician prohibits participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Lara Brewer

Assistant Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IRB_00061832

Identifier Type: -

Identifier Source: org_study_id

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