Observing Changes in Ventilation Pattern During Procedural Sedation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention, only ventilation monitoring

Other

Primary outcomes

Respiratory rate

Time frame: Measured for every breath observed throughout the endoscopy procedure
Tidal volume

Time frame: Measured for every breath observed throughout the endoscopy procedure
End-tidal CO2

Time frame: Measured for every breath observed throughout the endoscopy procedure

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 7, 2016
Registry last updated: Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed