NCT02825433

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.6 years

First QC Date

June 25, 2016

Last Update Submit

July 1, 2016

Conditions

Pulmonary Ventilation

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

No intervention, only ventilation monitoringOTHER
Patients receiving procedural sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving procedural sedation for endoscopy

You may qualify if:

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

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

June 25, 2016

First Posted

July 7, 2016

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 7, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share