ColonoscopyNCT02860143
Assessment of Ventilation Using Respiratory Volume Monitor Compared to Capnography During Intravenous Sedation
An observational study of Colonoscopy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
A. Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the capnograph C. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colonoscopy
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients receiving intravenous propofol for sedation, or general anesthesia with natural airway and breathing spontaneously will be recruited and will give written informed consent. The RVM data collection will end when the patient is discharged from the operating room.
Who may be able to join
- Inclusion Criteria: patient's ≥ 20 years of age receiving intravenous sedation, or intravenous general anesthesia with propofol.
Who cannot join
- Criteria: patients not able to give informed consent, Inability to place the PadSets on the thorax. Existence of an active implanted neurostimulator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02090
About this study
Official title: Assessment of Ventilation Using Respiratory Volume Monitor During Sedation With Intravenous Propofol as Compared to Capnography in Patients Receiving Intravenous Sedation.
- Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the capnograph C. Compare the incidence of missing or poor quality readings between the RVM and the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with adequate data quality on both devices) E. If RMV can identify respiratory obstruction. Capnography
Read the detailed description
Rationale for Proposed Research: Continuous respiratory monitoring using the ExSpiron System will be particularly beneficial to patients receiving intravenous propofol breathing spontaneously with natural airway. Assessment and management of respiratory function and early intervention when indicated is a multifaceted, complex task often complicated by the unavailability of a cohesive and continuous monitoring system to guide clinical decisions. The ExSpiron system is designed for these patients and is intended to address some of the limitations of the current generation of hospital monitors and to provide healthcare providers with continuous real-time data regarding the patient's respiratory status. Recent RVM data has shown that stratification of patients based on the MV % of predicted, prior to opioid dosing has made it possible to identify patients who are at risk for further decrease in MV and opioid-induced respiratory depression (OIRD).
- In the spontaneously breathing, non-ventilated patient, current monitoring devices do not provide continuous, objective non-invasive, continuous real time information of important respiratory parameters such as TV, MV and RR.
- Current monitoring of non-intubated patients mostly relies on oximetry data, subjective clinical assessment and occasionally EtCO2 measurements. In appropriate clinical settings, the ExSpiron system can provide direct quantitative measure of ventilation parameters for use in clinical assessment and trend prediction as well as response to medications and other interventions.
- Conditions
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| studying ventilation during sedation | Comparing ventilation during sedation with capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minute ventilation, tidal volume, and end-tidal carbon dioxide following propofol
Minute ventilation (MV) and tidal volume (TV) measured by the Respiratory Volume Monitor will be reported as percent of baseline established during normal breathing prior to sedation. The percent decrease in MV and TV following propofol will be compared to changes in end-tidal CO2 measured by capnography. The amount of time between propofol doses and changes in MV and TV and EtCO2 will be quantified and compared.
Measured: Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)
Secondary outcomes (1)
Comparison of Respiratory Rate measurement by Respiratory Volume Monitor and Capnography
Respiratory rate measurements from the respiratory volume monitor and capnography will be compared. The percent time that a respiratory rate reading is available will be quantified and compared.
Measured: Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhavani Shankar Kodali, Brigham and Women's Hospital
- Investigators
- Bhavani Kodali, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860143
- Sponsor's protocol ID
- 2014P001522
- Status last verified
- Jan 2018
- First submitted
- 28 Jul 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ventilation Using Respiratory Volume Monitor During Sedation With Intravenous Propofol as Compared to Capnography in Patients Receiving Intravenous Sedation.
- ClinicalTrials.gov ID
- NCT02860143
- Acronym / sponsor ID
- 2014P001522
- Conditions
- Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Aug 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.
- Determine if Respiratory Volume Monitor (RVM) can be used during procedural sedation to adequately monitor patient's respiratory status as compared to capnograph Aims B. Compare the time of capture of respiratory events (depression, arrest, etc…) on both the RVM and the capnograph C. Compare the incidence of missing or poor quality readings between the RVM and the capnograph D. Compare RR readings between the RVM and the capnograph (during periods with adequate data quality on both devices) E. If RMV can identify respiratory obstruction. Capnography
Detailed description
Rationale for Proposed Research: Continuous respiratory monitoring using the ExSpiron System will be particularly beneficial to patients receiving intravenous propofol breathing spontaneously with natural airway. Assessment and management of respiratory function and early intervention when indicated is a multifaceted, complex task often complicated by the unavailability of a cohesive and continuous monitoring system to guide clinical decisions. The ExSpiron system is designed for these patients and is intended to address some of the limitations of the current generation of hospital monitors and to provide healthcare providers with continuous real-time data regarding the patient's respiratory status. Recent RVM data has shown that stratification of patients based on the MV % of predicted, prior to opioid dosing has made it possible to identify patients who are at risk for further decrease in MV and opioid-induced respiratory depression (OIRD).
- In the spontaneously breathing, non-ventilated patient, current monitoring devices do not provide continuous, objective non-invasive, continuous real time information of important respiratory parameters such as TV, MV and RR.
- Current monitoring of non-intubated patients mostly relies on oximetry data, subjective clinical assessment and occasionally EtCO2 measurements. In appropriate clinical settings, the ExSpiron system can provide direct quantitative measure of ventilation parameters for use in clinical assessment and trend prediction as well as response to medications and other interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| studying ventilation during sedation | – | –Comparing ventilation during sedation with capnography |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients receiving intravenous propofol for sedation, or general anesthesia with natural airway and breathing spontaneously will be recruited and will give written informed consent. The RVM data collection will end when the patient is discharged from the operating room.
Key inclusion criteria (1 listed)
- Inclusion Criteria: patient's ≥ 20 years of age receiving intravenous sedation, or intravenous general anesthesia with propofol.
Key exclusion criteria (1 listed)
- Criteria: patients not able to give informed consent, Inability to place the PadSets on the thorax. Existence of an active implanted neurostimulator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in minute ventilation, tidal volume, and end-tidal carbon dioxide following propofol
Time frame: Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)
Minute ventilation (MV) and tidal volume (TV) measured by the Respiratory Volume Monitor will be reported as percent of baseline established during normal breathing prior to sedation. The percent decrease in MV and TV following propofol will be compared to changes in end-tidal CO2 measured by capnography. The amount of time between propofol doses and changes in MV and TV and EtCO2 will be quantified and compared.
1 secondary outcome
Comparison of Respiratory Rate measurement by Respiratory Volume Monitor and Capnography
Time frame: Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)
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 18 Jan 2018.
- 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.
Bhavani Kodali, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Brigham and Women's Hospital 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 1 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 Jan 2018. 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?
Change in minute ventilation, tidal volume, and end-tidal carbon dioxide following propofol (time frame: Starting approximately 10 min prior to colonoscopy and continuing until end of colonoscopy (average time: 45-60 minutes)). 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 Jan 2018.