Observing Changes in Ventilation Pattern During Procedural Sedation

July 1, 2016 updated by: Lara Brewer, University of Utah
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving procedural sedation for endoscopy

Description

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
  • (ii) standard colonoscopy exclusion criteria used at the GI lab at the University of Utah
  • (iii) patients with severe medical conditions that in the view of the acting physician prohibits participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention, only ventilation monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory rate
Time Frame: Measured for every breath observed throughout the endoscopy procedure
Measured for every breath observed throughout the endoscopy procedure
Tidal volume
Time Frame: Measured for every breath observed throughout the endoscopy procedure
Measured for every breath observed throughout the endoscopy procedure
End-tidal CO2
Time Frame: Measured for every breath observed throughout the endoscopy procedure
Measured for every breath observed throughout the endoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 25, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Estimate)

July 7, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IRB_00061832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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