Pulmonary VentilationNCT02825433
Observing Changes in Ventilation Pattern During Procedural Sedation
An observational study of Pulmonary Ventilation, run by University of Utah.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Ventilation
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving procedural sedation for endoscopy
Who may be able to join
- (i) ASA I, II, or III
- (ii) patients older than eighteen
- (iii) English speaking
- (iv) undergoing a colonoscopy procedure and receiving procedural sedation
Who cannot join
- (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
About this study
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.
Read the 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.
- Conditions
- Pulmonary Ventilation
- Being tested
- No intervention, only ventilation monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only ventilation monitoringOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention, only ventilation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Measured: Measured for every breath observed throughout the endoscopy procedure
Tidal volume
Measured: Measured for every breath observed throughout the endoscopy procedure
End-tidal CO2
Measured: Measured for every breath observed throughout the endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Brewer, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825433
- Sponsor's protocol ID
- IRB_00061832
- Status last verified
- Jul 2016
- First submitted
- 25 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing Changes in Ventilation Pattern During Procedural Sedation
- ClinicalTrials.gov ID
- NCT02825433
- Acronym / sponsor ID
- IRB_00061832
- Conditions
- Pulmonary Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving procedural sedation | – | Other: No intervention, only ventilation monitoringThe investigators collected ventilation data for each breath (respiratory rate, tidal volume, and end-tidal CO2) for all patients receiving procedural sedation for endoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving procedural sedation for endoscopy
Key inclusion criteria (4 listed)
- (i) ASA I, II, or III
- (ii) patients older than eighteen
- (iii) English speaking
- (iv) undergoing a colonoscopy procedure and receiving procedural sedation
Key exclusion criteria (3 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, only ventilation monitoring | Other | Patients receiving procedural sedation |
Primary outcome
Respiratory rate
Time frame: Measured for every breath observed throughout the endoscopy procedure
Tidal volume
Time frame: Measured for every breath observed throughout the endoscopy procedure
End-tidal CO2
Time frame: Measured for every breath observed throughout the endoscopy procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Ventilation, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: Measured for every breath observed throughout the endoscopy procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.