HypoxiaNCT03369197
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
A study testing Nasal Mask in people with Hypoxia and Endoscopy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Endoscopy, Anesthesia Morbidity
- What is being tested?
- Nasal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 23 Oct 2019
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.
Who cannot join
- Left ventricular Assist Device
- Severe Pulmonary Hypertension
- Ejection fraction less than 35 percent
- Active Congestive Heart Failure Exacerbation
- Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
- Topical lidocaine administration
- Pregnancy
- Previous enrollment in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.
Read the detailed description
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.
- Conditions
- Hypoxia, Endoscopy, Anesthesia Morbidity
- Being tested
- Nasal Mask, Control: Nasal Cannula
- Keywords
- procedural sedation, monitored anesthesia care, endoscopy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal MaskDevice
Also called Intervention: Nasal anesthesia mask with positive pressure
Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
Control: Nasal CannulaDevice
Also called Standard Care
Nasal cannula as per usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Nasal Mask | Experimental | Nasal anesthesia mask with positive pressure Receives: Device: Nasal Mask |
| Control: Nasal cannula | Active comparator | Nasal Cannula with standard care Receives: Device: Control: Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.
Measured: Approximately 1 hour
Secondary outcomes (6)
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
Evaluate hypoventilation in subjects undergoing procedural sedation for endoscopy by transcutaneous carbon dioxide monitoring in millimeters of mercury (mmHg).
Measured: Approximately 1 hour
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
Evaluate hypoventilation by respiratory volume monitoring for minute ventilation. Reported result is the percentage decrease from baseline in minute ventilation.
Measured: Approximately 1 hour
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation
Correlate respiratory volume monitoring transcutaneous carbon dioxide measurement with number of airway maneuvers to identify mechanism of hypoventilation as predominately obstructive or due to respiratory rate or tidal volume.
Measured: Approximately 1 hour
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
Depth of anesthesia by processed electroencephalogram (EEG) bispectral analysis, which is a standard monitor of anesthetic depth using a calibrated dimensionless index that ranges from 0 to 100, with lower numbers corresponding to a deeper anesthetic state.
Measured: Approximately 1 hour
Hypoxia Duration
The total time in seconds of oxygen saturation below 90 percent will be recorded
Measured: Approximately 1 hour
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
In subjects experiencing hypoxia during sedation, the total number of episodes of hypoxia for all participants will be recorded.
Measured: Approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start30 Oct 2017
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
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 HypoxiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laeben Lester, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369197
- Sponsor's protocol ID
- IRB00118466
- Status last verified
- Sep 2022
- First submitted
- 28 Nov 2017
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Intervention to Reduce the Incidence of Hypoxia With Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT03369197
- Acronym / sponsor ID
- IRB00118466
- Conditions
- Hypoxia, Endoscopy, Anesthesia Morbidity
- Keywords
- procedural sedation, monitored anesthesia care, endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.
Detailed description
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Nasal Mask | Experimental | Device: Nasal MaskNasal anesthesia mask with positive pressure |
| Control: Nasal cannula | Active comparator | Device: Control: Nasal CannulaNasal Cannula with standard care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.
Key exclusion criteria (8 listed)
- Left ventricular Assist Device
- Severe Pulmonary Hypertension
- Ejection fraction less than 35 percent
- Active Congestive Heart Failure Exacerbation
- Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
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 |
|---|---|---|
| Nasal MaskAlso: Intervention: Nasal anesthesia mask with positive pressureNasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve | Device | Intervention: Nasal Mask |
| Control: Nasal CannulaAlso: Standard CareNasal cannula as per usual care | Device | Control: Nasal cannula |
Primary outcome
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event
Time frame: Approximately 1 hour
Number of subjects undergoing procedural sedation for endoscopy with at least one hypoxic event, defined as oxygen saturation less than 90 percent for 15 seconds.
6 secondary outcomes
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Transcutaneous Carbon Dioxide Monitoring
Time frame: Approximately 1 hour
Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy as Assessed by Respiratory Volume Monitoring
Time frame: Approximately 1 hour
Mechanism of Hypoventilation in Subjects Undergoing Procedural Sedation for Endoscopy and Hypoventilation
Time frame: Approximately 1 hour
Depth of Anesthesia in Subjects Undergoing Procedural Sedation for Endoscopy
Time frame: Approximately 1 hour
Hypoxia Duration
Time frame: Approximately 1 hour
Total Number of Hypoxic Events in Subjects That Experienced Hypoxia
Time frame: Approximately 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Laeben Lester, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Mask in people with Hypoxia and Endoscopy, run by Johns Hopkins 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 1 inclusion and 8 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 18 Oct 2022. 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 21 Dec 2020). 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?
Hypoxia Rate as Assessed by Number of Participants With at Least One Hypoxic Event (time frame: Approximately 1 hour). 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 18 Oct 2022.