Respiratory DepressionNCT04017702
Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
An observational study of Respiratory Depression, run by Yale University at 1 site in United States.
Trial summary
Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Expiron respirator
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 20 Feb 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group A; which will involve pregnant women with gestational age between 32-40 weeks. It will take place at: i. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine. ii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale) Group B; in post anesthesia care units (PACU) and surgical floor: 100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA). Group C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.
Who may be able to join
- Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.
Who cannot join
- Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
- Patients allergic to morphine.
- Have an ASA class > IV
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06519-1362
About this study
Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.
Read the detailed description
Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients
- Conditions
- Respiratory Depression
- Being tested
- Expiron respirator
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiron respiratorDevice
Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with gestational age between 32-40 weeks. | 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine. | |
| Patients post anesthesia care units (PACU) and surgical floor. | 100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA). | |
| Patients in step down/ICU. | 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.The Expiron will provide continuous information about the respiratory status (tidal volume, respiratory rate and minute ventilation) of non-intubated patients specifically: sleeping or awake; with the use of incentive spirometry; the response to medications and other interventions (such as paravertebral/epidural block); the need for endotracheal re-intubation. Receives: Device: Expiron respirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative respiratory depression
To define the incidence of postoperative respiratory depression between 2 devices.
Measured: 1 year
Secondary outcomes (1)
Detection of postoperative respiratory depression in high risk patients.
To determine the agreement between these 2 devices in detection of postoperative respiratory depression in high risk patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start20 Jun 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymen Alian, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017702
- Sponsor's protocol ID
- 2000021197
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
- ClinicalTrials.gov ID
- NCT04017702
- Acronym / sponsor ID
- 2000021197
- Conditions
- Respiratory Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 12 Jul 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.
Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.
Detailed description
Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with gestational age between 32-40 weeks. | – | –100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine. |
| Patients post anesthesia care units (PACU) and surgical floor. | – | –100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA). |
| Patients in step down/ICU. | – | Device: Expiron respirator50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.The Expiron will provide continuous information about the respiratory status (tidal volume, respiratory rate and minute ventilation) of non-intubated patients specifically: sleeping or awake; with the use of incentive spirometry; the response to medications and other interventions (such as paravertebral/epidural block); the need for endotracheal re-intubation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group A; which will involve pregnant women with gestational age between 32-40 weeks. It will take place at: i. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine. ii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale) Group B; in post anesthesia care units (PACU) and surgical floor: 100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA). Group C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.
Key inclusion criteria (1 listed)
- Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.
Key exclusion criteria (3 listed)
- Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
- Patients allergic to morphine.
- Have an ASA class > IV
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 |
|---|---|---|
| Expiron respiratorRespiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing. | Device | Patients in step down/ICU. |
Primary outcome
The incidence of postoperative respiratory depression
Time frame: 1 year
To define the incidence of postoperative respiratory depression between 2 devices.
1 secondary outcome
Detection of postoperative respiratory depression in high risk patients.
Time frame: 1 year
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 1 Apr 2022.
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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.
Aymen Alian, MD principal investigator
Yale University
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 Respiratory Depression, run by Yale 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 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 Apr 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?
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?
The incidence of postoperative respiratory depression (time frame: 1 year). 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 Apr 2022.