LaryngospasmNCT04159116
Prevention and Treatment of Laryngospasm and Hypoxemia Based on Risk Factors in Adult Outpatients Undergoing EGD
A study testing Prophylactic suctioning when clinically indicated in people with Laryngospasm and Hypoxemia, run by Envision Healthcare Scientific Intelligence, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation < 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laryngospasm, Hypoxemia
- What is being tested?
- Prophylactic suctioning when clinically indicated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 19 Mar 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- English speaking
- Mentally competent to sign their own consent for treatment
Who cannot join
- Poor incisor teeth stability
- Anticipated procedure of greater than 30 minutes
- History of facial or oral surgery and a baseline oxygen saturation of less than 95% on room air
Trial locations and contacts
1 site in 1 country.
United States1 site
Three Rivers Endoscopy
Moon Township, Pennsylvania, 15108
About this study
Official title: Development of a Protocol for Prevention and Treatment of Laryngospasm and Other Causes of Hypoxemia Based on Identified Risk Factors in Adult Outpatients Undergoing Esophagogastroduodenoscopy (EGD) Under Monitored Anesthesia Care (MAC)
The purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation < 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy outpatients.
- Conditions
- Laryngospasm, Hypoxemia
- Being tested
- Prophylactic suctioning when clinically indicated
- Medical subject headings
- Laryngismus, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic suctioning when clinically indicatedOther
Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation
| Study group | Role | What they receive |
|---|---|---|
| Suctioned Prior to Endoscope | Experimental | This group will be suctioned prophylactically after sedation but prior to introduction of endoscope. Receives: Other: Prophylactic suctioning when clinically indicated |
| Standard of Care | Other | This group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation. Receives: Other: Prophylactic suctioning when clinically indicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laryngospasm during EGDs
Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs.
Measured: 2 hours
Identify risk factors for the development of hypoxemia during EGD
These risk factors include both patient factors (ASA class, history of cardiopulmonary disease, BMI, social history, Obstructive Sleep Apnea, STOP-BANG scores and age) and provider-chosen factors (medications given, airway interventions, percent and flow of oxygen in liters per minute, and whether or not the patient was suctioned prior to or during the procedure).
Measured: 2 hours
Secondary outcomes (2)
Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of copious secretions, choking, desaturation, and shortened or aborted procedures.
Measured: 2 hours
Identify the various causes of hypoxemia during EGD
These risk include apnea, hypoventilation, laryngospasm, or other cause of airway obstruction
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start4 Nov 2019
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngospasmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Envision Healthcare Scientific Intelligence, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Morrison, DNP, CRNA, Principal investigator, Envision Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159116
- Sponsor's protocol ID
- TRE2019-EGD01
- Status last verified
- Mar 2021
- First submitted
- 7 Nov 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Protocol for Prevention and Treatment of Laryngospasm and Other Causes of Hypoxemia Based on Identified Risk Factors in Adult Outpatients Undergoing Esophagogastroduodenoscopy (EGD) Under Monitored Anesthesia Care (MAC)
- ClinicalTrials.gov ID
- NCT04159116
- Acronym / sponsor ID
- TRE2019-EGD01
- Conditions
- Laryngospasm, Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Envision Healthcare Scientific Intelligence, Inc.University, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- 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 purpose of this study is to identify patient and provider-chosen factors that put patients at risk for the development of hypoxemia (oxygen saturation < 90% for 5 seconds) during endoscopy and to use this knowledge to develop a treatment protocol for specific causes of hypoxemia in adult esophagogastroduodenoscopy outpatients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suctioned Prior to Endoscope | Experimental | Other: Prophylactic suctioning when clinically indicatedThis group will be suctioned prophylactically after sedation but prior to introduction of endoscope. |
| Standard of Care | Other | Other: Prophylactic suctioning when clinically indicatedThis group will be suctioned by anesthesia providers when clinically indicated by copious secretions, coughing, choking or desaturation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 18 years
- English speaking
- Mentally competent to sign their own consent for treatment
Key exclusion criteria (3 listed)
- Poor incisor teeth stability
- Anticipated procedure of greater than 30 minutes
- History of facial or oral surgery and a baseline oxygen saturation of less than 95% on room air
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 |
|---|---|---|
| Prophylactic suctioning when clinically indicatedSuctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation | Other | Standard of Care, Suctioned Prior to Endoscope |
Primary outcome
Incidence of laryngospasm during EGDs
Time frame: 2 hours
Determine if prophylactic suctioning after sedation but prior to introduction of endoscope changes the incidence of laryngospasm during EGDs.
Identify risk factors for the development of hypoxemia during EGD
Time frame: 2 hours
These risk factors include both patient factors (ASA class, history of cardiopulmonary disease, BMI, social history, Obstructive Sleep Apnea, STOP-BANG scores and age) and provider-chosen factors (medications given, airway interventions, percent and flow of oxygen in liters per minute, and whether or not the patient was suctioned prior to or during the procedure).
2 secondary outcomes
Incidence of copious secretions, choking, desaturation, and shortened or aborted procedures
Time frame: 2 hours
Identify the various causes of hypoxemia during EGD
Time frame: 2 hours
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 17 Mar 2021.
- 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.
Suzanne Morrison, DNP, CRNA principal investigator
Envision Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic suctioning when clinically indicated in people with Laryngospasm and Hypoxemia, run by Envision Healthcare Scientific Intelligence, Inc. 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 17 Mar 2021. 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?
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?
Incidence of laryngospasm during EGDs (time frame: 2 hours). The study lists 2 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 17 Mar 2021.