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Observing Changes in Ventilation Pattern During Procedural Sedation

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ClinicalTrials.gov Identifier: NCT02825433
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
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.

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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 ]


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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
Criteria

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
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Responsible Party: Lara Brewer, Assistant Research Professor, University of Utah
ClinicalTrials.gov 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