Joint DislocationNCT02410707
Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults
A study testing Nitrous Oxide arm, Propofol and Oxygen in people with Joint Dislocation and Perianal Abscess, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Dislocation, Perianal Abscess, Abscess
- What is being tested?
- Nitrous Oxide arm, Propofol and Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spontaneous respirations
- 18 years of age and older
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an Emergency Department procedure.
- Ability to provide informed consent.
Who cannot join
- Comorbidities that affect ventilation, perfusion, or metabolism
- Intubated
- Cardiopulmonary instability
- Major trauma
- Sepsis
- American Society of Anesthesiologists (ASA) class 3, 4, and 5.
Show all 12Show fewer
- Inability to provide informed consent
- Nursing home residents
- Age less than 18 years
- Non English speaking
- Pregnant women
- Under police custody
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults, a Pilot Study
The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.
Read the detailed description
This pilot study will be conducted in a prospective, non-randomized fashion using a convenience sample of 100 subjects undergoing sedation for Emergency Department procedures.
Recruitment Methods The research associates as well as the health care team (both residents and attending physicians) will screen patients who may need procedural sedation in the Emergency Department and may qualify for the study. Research associates will use the Medical Record
Procedures Involved in the Research Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study. After informed consent is obtained and prior to starting the sedation, standard vital sign monitoring will be placed on the patient (electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, and capnography). Level of consciousness will be determined using the modified Ramsay scale, which will be assessed at baseline. The Entitled Carbon Di Oxide (CO2) monitor will be used as the primary device to measure Entitled Carbon Di Oxide (CO2), with a nasal cannula capable of delivering supplemental oxygen and measuring Entitled CO2.
The Nitrous Oxide gas mixer system will be used as the primary nitrous oxide delivery device. It will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. It uses a patient driven demand valve system that is hand held. This device provides a consistent, fixed 50%/50% blend of nitrous oxide (N2O) and oxygen (O2), eliminates the need to titrate, and provides fixed concentrations for controlled and consistent dosing. The device comparator detects dosing imbalance to protect against hypoxic mixtures, it cannot deliver nitrous gas without concurrent oxygen, and the device has an anti-asphyxia valve override. The on demand valve requires patient inspiration to trigger dosing. This portable device scavenges exhaled waste gases for environmental safety, as well as a key mechanism that renders the system inoperable without it for security.
After informed consent, the patient will fill out a pre procedure questionnaire and a 100 mm VAS baseline pain scale. The patient will be given the mask for delivery of nitrous oxide, and instructed on its use. The research associate will mark the time the patient began using the device electronically. Once IV access is established, and the team and patient are ready to begin the procedure, the nitrous oxide mask will be removed, and a 100% non rebreather mask delivering 15 liters a minute of supplemental oxygen will be placed on the patients face. The loading dose of propofol will then be administered immediately. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.
The subject's clinical data and sedation information (refer to data management) will be entered into a standardized data collection form. The data will be continuously recorded throughout the sedation and recovery periods. Study will end when the subjects recovers back to baseline mental status.
Vital signs will be flagged electronically when a physician intervenes for clinical respiratory depression. Respiratory depression will be defined as peripheral Oxygen saturation below 92%, Entitled CO2 level above 50, a rise or decrease of 10% above or below baseline, the loss of the Entitled CO2 waveform for more than 15 seconds. Level of consciousness will be determined using the modified Ramsay scale, which will be recorded at baseline and at the point of deepest sedation. Once the procedure is complete, and the patient is deemed back to their mental status baseline, they will fill out a post procedure satisfaction questionnaire, and a 100 mm VAS scale. They will be asked about procedure recall. The physician and nurse involved will also fill out a post procedure questionnaire.
System for screening, and they will be in charge of informed consent, enrollment, placement of the capnography monitor, as well as data collection. The health care team will be in charge of the procedural sedation and all other management.
- Conditions
- Joint Dislocation, Perianal Abscess, Abscess
- Being tested
- Nitrous Oxide arm, Propofol, Oxygen
- Keywords
- procedural sedation, procedural pain, procedural anxiolysis
- Medical subject headings
- Joint Dislocations, Abscess, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide armDrug
Also called Nitrous Oxide, Sedera Gas Mixer, Propofol Sedation, Procedural Sedation
Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
PropofolDrug
Also called Diprivan
The loading dose of propofol will be administered immediately after nitrous oxide discontinuation. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.
OxygenDrug
Also called O2
If pulse oximetry declines to less than 92%, subject will be placed on nasal cannula with administration of 2 liter flow of oxygen and titrated in increments of 1 L flow to maintain pulse oximetry greater than 92%
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide Arm | Experimental | Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing. Receives: Drug: Nitrous Oxide arm; Drug: Propofol; Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Respiratory Depression Events
End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds
Measured: day 1
Secondary outcomes (7)
Total Number of Airway Repositioning Events
Presence or absence of physician intervention requiring airway repositioning by provider due to decreased oxygen saturation less than 92%
Measured: day 1
Total Number of Events Requiring Additional Oxygen
Presence or absence of physician intervention requiring additional oxygen via nasal cannula or non rebreather by the provider due to oxygen saturation less than 92%
Measured: day 1
Total Number of Positive Pressure Ventilation Events
Presence or absence of physician intervention requiring positive pressure ventilation via a bag valve max due to decreased oxygen saturation less than 92%
Measured: day 1
Total Number of Endotracheal Intubation Events
Presence or absence of physician intervention requiring endotracheal intubation by provider due to decreased oxygen saturation less than 92%
Measured: day 1
Total Number of Physical Stimulation Events
Presence or absence of physician intervention requiring physical stimulation by the provider due to decreased oxygen saturation less than 92%
Measured: day 1
Patient, Physician, and Nurse Satisfaction Surveys
Patient satisfaction with use of Nitrous Oxide in anxiolysis and pain control
Measured: day 1
Post-Procedure VAS Pain Score
Visual Analog Scale (0-100mm), where 0 mm is minimum pain, and 100 mm is maximum pain.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2018
- Study completionFeb 2018
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 Joint DislocationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Herres, Albert Einstein Healthcare Network
- Investigators
- Joseph Herres, DO, Principal investigator, Albert Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410707
- Sponsor's protocol ID
- HN4641
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2015
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults, a Pilot Study
- ClinicalTrials.gov ID
- NCT02410707
- Acronym / sponsor ID
- HN4641
- Conditions
- Joint Dislocation, Perianal Abscess, Abscess
- Keywords
- procedural sedation, procedural pain, procedural anxiolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Posted 8 Apr 2020
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 describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.
Detailed description
This pilot study will be conducted in a prospective, non-randomized fashion using a convenience sample of 100 subjects undergoing sedation for Emergency Department procedures.
Recruitment Methods The research associates as well as the health care team (both residents and attending physicians) will screen patients who may need procedural sedation in the Emergency Department and may qualify for the study. Research associates will use the Medical Record
Procedures Involved in the Research Initial medical assessment will be made in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patient meets eligibility criteria, then they will be approached by a research associate for enrollment in the study. After informed consent is obtained and prior to starting the sedation, standard vital sign monitoring will be placed on the patient (electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, and capnography). Level of consciousness will be determined using the modified Ramsay scale, which will be assessed at baseline. The Entitled Carbon Di Oxide (CO2) monitor will be used as the primary device to measure Entitled Carbon Di Oxide (CO2), with a nasal cannula capable of delivering supplemental oxygen and measuring Entitled CO2.
The Nitrous Oxide gas mixer system will be used as the primary nitrous oxide delivery device. It will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. It uses a patient driven demand valve system that is hand held. This device provides a consistent, fixed 50%/50% blend of nitrous oxide (N2O) and oxygen (O2), eliminates the need to titrate, and provides fixed concentrations for controlled and consistent dosing. The device comparator detects dosing imbalance to protect against hypoxic mixtures, it cannot deliver nitrous gas without concurrent oxygen, and the device has an anti-asphyxia valve override. The on demand valve requires patient inspiration to trigger dosing. This portable device scavenges exhaled waste gases for environmental safety, as well as a key mechanism that renders the system inoperable without it for security.
After informed consent, the patient will fill out a pre procedure questionnaire and a 100 mm VAS baseline pain scale. The patient will be given the mask for delivery of nitrous oxide, and instructed on its use. The research associate will mark the time the patient began using the device electronically. Once IV access is established, and the team and patient are ready to begin the procedure, the nitrous oxide mask will be removed, and a 100% non rebreather mask delivering 15 liters a minute of supplemental oxygen will be placed on the patients face. The loading dose of propofol will then be administered immediately. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.
The subject's clinical data and sedation information (refer to data management) will be entered into a standardized data collection form. The data will be continuously recorded throughout the sedation and recovery periods. Study will end when the subjects recovers back to baseline mental status.
Vital signs will be flagged electronically when a physician intervenes for clinical respiratory depression. Respiratory depression will be defined as peripheral Oxygen saturation below 92%, Entitled CO2 level above 50, a rise or decrease of 10% above or below baseline, the loss of the Entitled CO2 waveform for more than 15 seconds. Level of consciousness will be determined using the modified Ramsay scale, which will be recorded at baseline and at the point of deepest sedation. Once the procedure is complete, and the patient is deemed back to their mental status baseline, they will fill out a post procedure satisfaction questionnaire, and a 100 mm VAS scale. They will be asked about procedure recall. The physician and nurse involved will also fill out a post procedure questionnaire.
System for screening, and they will be in charge of informed consent, enrollment, placement of the capnography monitor, as well as data collection. The health care team will be in charge of the procedural sedation and all other management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide Arm | Experimental | Drug: Nitrous Oxide arm, Drug: Propofol, Drug: OxygenPatients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spontaneous respirations
- 18 years of age and older
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an Emergency Department procedure.
- Ability to provide informed consent.
Key exclusion criteria (12 listed)
- Comorbidities that affect ventilation, perfusion, or metabolism
- Intubated
- Cardiopulmonary instability
- Major trauma
- Sepsis
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 |
|---|---|---|
| Nitrous Oxide armAlso: Nitrous Oxide, Sedera Gas Mixer, Propofol Sedation, Procedural SedationPatients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing. | Drug | Nitrous Oxide Arm |
| PropofolAlso: DiprivanThe loading dose of propofol will be administered immediately after nitrous oxide discontinuation. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin. | Drug | Nitrous Oxide Arm |
| OxygenAlso: O2If pulse oximetry declines to less than 92%, subject will be placed on nasal cannula with administration of 2 liter flow of oxygen and titrated in increments of 1 L flow to maintain pulse oximetry greater than 92% | Drug | Nitrous Oxide Arm |
Primary outcome
Total Number of Respiratory Depression Events
Time frame: day 1
End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds
7 secondary outcomes
Total Number of Airway Repositioning Events
Time frame: day 1
Total Number of Events Requiring Additional Oxygen
Time frame: day 1
Total Number of Positive Pressure Ventilation Events
Time frame: day 1
Total Number of Endotracheal Intubation Events
Time frame: day 1
Total Number of Physical Stimulation Events
Time frame: day 1
Patient, Physician, and Nurse Satisfaction Surveys
Time frame: day 1
Post-Procedure VAS Pain Score
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- 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.
Joseph Herres, DO principal investigator
Albert Einstein 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 Nitrous Oxide arm, Propofol and Oxygen in people with Joint Dislocation and Perianal Abscess, run by Albert Einstein Healthcare Network 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 4 inclusion and 12 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 8 Apr 2020. 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 8 Apr 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?
Total Number of Respiratory Depression Events (time frame: day 1). 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 8 Apr 2020.