Observing Changes in Ventilation Pattern During Procedural Sedation

Completed

• Conditions: Pulmonary Ventilation
• Interventions: Other: No intervention, only ventilation monitoring

• Registration Number: NCT02825433
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2016-06-25
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-01
• Last Update Submitted: 2016-07-01
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving procedural sedation	No intervention, only ventilation monitoring	The investigators collected ventilation data for each breath (respiratory rate, tidal volume, and end-tidal CO2) for all patients receiving procedural sedation for endoscopy.

Primary Outcome Measures

Name	Time	Method
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