Oxygen Administration During Deep SedationNCT02219464
Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients
A study testing Nasopharyngeal catheter, Nasal Cannula and Oxygen Supplementation in people with Oxygen Administration During Deep Sedation, run by Vanderbilt University at 1 site in United States.
Trial summary
The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under moderate sedation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Oxygen Administration During Deep Sedation
- What is being tested?
- Nasopharyngeal catheter, Nasal Cannula and Oxygen Supplementation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients greater than 16 years of age
- Patients who present for oral surgery or esophagoduodenography and colonoscopy
- Patients who undergo intravenous sedation
Who cannot join
- Patients who require endotracheal intubation
- ASA class 4 or higher
- Existing esophageal disease such as a perforation or varices
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under moderate sedation.
- Being tested
- Nasopharyngeal catheter, Nasal Cannula, Oxygen Supplementation, Sedation
- Keywords
- nasopharyngeal catheter, nasal cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal catheterDevice
Nasal CannulaDevice
Oxygen SupplementationProcedure or surgery
Initially set at 3 liters/minute
SedationProcedure or surgery
Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal catheter | Active comparator | Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. Receives: Device: Nasopharyngeal catheter; Procedure: Oxygen Supplementation; Procedure: Sedation |
| Nasal Cannula | Other | Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. Receives: Device: Nasal Cannula; Procedure: Oxygen Supplementation; Procedure: Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Oxygen Saturations Below 92%
Measured: During surgical procedure
Secondary outcomes (1)
Number of Participants Who Needed Airway Assistance Interventions
(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).
Measured: During surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oxygen Administration During Deep SedationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Alvis, Vanderbilt University
- Investigators
- Bret Alvis, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219464
- Sponsor's protocol ID
- 130627
- Status last verified
- May 2016
- First submitted
- 12 Aug 2014
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients
- ClinicalTrials.gov ID
- NCT02219464
- Acronym / sponsor ID
- 130627
- Keywords
- nasopharyngeal catheter, nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under moderate sedation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal catheter | Active comparator | Device: Nasopharyngeal catheter, Procedure: Oxygen Supplementation, Procedure: SedationPatients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups. |
| Nasal Cannula | Other | Device: Nasal Cannula, Procedure: Oxygen Supplementation, Procedure: SedationPatients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients greater than 16 years of age
- Patients who present for oral surgery or esophagoduodenography and colonoscopy
- Patients who undergo intravenous sedation
Key exclusion criteria (3 listed)
- Patients who require endotracheal intubation
- ASA class 4 or higher
- Existing esophageal disease such as a perforation or varices
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 |
|---|---|---|
| Nasopharyngeal catheter | Device | Nasopharyngeal catheter |
| Nasal Cannula | Device | Nasal Cannula |
| Oxygen SupplementationInitially set at 3 liters/minute | Procedure or surgery | Nasal Cannula, Nasopharyngeal catheter |
| SedationMidazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist. | Procedure or surgery | Nasal Cannula, Nasopharyngeal catheter |
Primary outcome
Number of Participants With Oxygen Saturations Below 92%
Time frame: During surgical procedure
1 secondary outcome
Number of Participants Who Needed Airway Assistance Interventions
Time frame: During surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Oxygen Administration During Deep Sedation
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HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
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Enrolling by invitationPhase 4
Usefulness of High-flow Oxygen Therapy of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation
Hypoxemia During Surgery
Not yet recruitingObservational study
The Effect of Oxygen Flow Rate on End-tidal CO2 During Deep Sedation
Capnography
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.
Bret Alvis, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal catheter, Nasal Cannula and Oxygen Supplementation in people with Oxygen Administration During Deep Sedation, run by Vanderbilt University at 1 site in United States.
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 3 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Oxygen Saturations Below 92% (time frame: During surgical procedure). 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 1 Jun 2017.