Observing Changes in Ventilation Pattern During Procedural Sedation

Pulmonary Ventilation Clinical Trial

Official title:

Observing Changes in Ventilation Pattern During Procedural Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825433
• Other study ID #: IRB_00061832
• Status: Completed
• Phase: N/A
• First received: June 25, 2016
• Last updated: July 1, 2016
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: July 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Ventilation

Intervention

Other:
• No intervention, only ventilation monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate		Measured for every breath observed throughout the endoscopy procedure	No
Primary	Tidal volume		Measured for every breath observed throughout the endoscopy procedure	No
Primary	End-tidal CO2		Measured for every breath observed throughout the endoscopy procedure	No