Observing Changes in Ventilation Pattern During Procedural Sedation

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT02825433

Collaborator

(none)

160

Enrollment

Duration (Months)

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Aug 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Respiratory rate [Measured for every breath observed throughout the endoscopy procedure]
Tidal volume [Measured for every breath observed throughout the endoscopy procedure]
End-tidal CO2 [Measured for every breath observed throughout the endoscopy procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lara Brewer, Assistant Research Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT02825433

Other Study ID Numbers:

IRB_00061832

First Posted:

Jul 7, 2016

Last Update Posted:

Jul 7, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jul 7, 2016