Working… Menu

Observing Changes in Ventilation Pattern During Procedural Sedation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825433
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Information provided by (Responsible Party):
Lara Brewer, University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Ventilation Other: No intervention, only ventilation monitoring

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observing Changes in Ventilation Pattern During Procedural Sedation
Study Start Date : August 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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

Primary Outcome Measures :
  1. Respiratory rate [ Time Frame: Measured for every breath observed throughout the endoscopy procedure ]
  2. Tidal volume [ Time Frame: Measured for every breath observed throughout the endoscopy procedure ]
  3. End-tidal CO2 [ Time Frame: Measured for every breath observed throughout the endoscopy procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving procedural sedation for endoscopy

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
Layout table for additonal information
Responsible Party: Lara Brewer, Assistant Research Professor, University of Utah Identifier: NCT02825433    
Other Study ID Numbers: IRB_00061832
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No