Hypotension on InductionNCT04299776
CirQPOD Shoulder Study
A study testing CirQPOD and Standard airway management in people with Hypotension on Induction, run by Zoll Medical Corporation at 1 site in United States.
Trial summary
Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- CirQPOD and Standard airway management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 28 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- American Society of Anesthesiologists (ASA) physical status class ≤3
- Scheduled for surgery in sitting/ beach-chair positions under general anesthesia in the Cleveland Clinic main campus
- Planned length of surgery >60 minutes
Who cannot join
- Severe peripheral vascular disease or other contraindication for use of vasopressor infusion
- Obstructive lung disease - moderate or severe asthma or COPD
- Baseline hypoxemia (SpO2<92% on room air)
- Body Mass Index (BMI) >35
- Congestive heart failure
- Pneumothorax or hemothorax
Show all 9Show fewer
- Uncontrolled hemorrhage
- Planned intraoperative hypotension
- Contraindication to trans-esophageal echocardiography (esophageal stricture, surgery involving the esophagus or stomach)
Trial locations and contacts
1 site in 1 country.
United States1 site
Outcomes Research, Anesthesia Institute, Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: A Randomized Clinical Trial on the Effects of Active Intrathoracic Pressure Regulation Therapy on Hemodynamic Stability During Shoulder Surgery in the Sitting Position
Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications.
The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.
- Conditions
- Hypotension on Induction
- Being tested
- CirQPOD, Standard airway management
- Keywords
- Intraoperative hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CirQPODDevice
CirQPOD is connected between the wye piece on ventilator/anesthesia machine tubing and the patient's airway and generates negative intrathoracic pressure during the expiratory phase of ventilation which has been shown to improve blood flow.
Standard airway managementDevice
Standard airway management during surgery (PEEP of +5 cmH2O)
| Study group | Role | What they receive |
|---|---|---|
| IPR therapy | Experimental | Intrathoracic pressure regulation (IPR) therapy level of -10 cmH2O (-7 cmH2O for run-in) provided by the CirQPOD device during shoulder surgery in the sitting position Receives: Device: CirQPOD |
| Standard airway | Active comparator | Standard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position Receives: Device: Standard airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenylephrine use
Amount of phenylephrine required to maintain MAP of 80±5 mmHg
Measured: from device placement to start of wound closure, a period of up to four hours
Secondary outcomes (3)
Pulmonary artery pressure
pressure in the pulmonary artery as measured by transesophageal echocardiography (TEE)
Measured: at least two minutes after IPR level of -10 cmH2O has been set
Atelectasis
presence and amount of atelectasis as determined by chest computerized tomography (CT)
Measured: first day post-op
PaO2
post-operative partial arterial oxygen pressure measured by arterial blood gas (ABG)
Measured: at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start28 Jan 2020
- Primary completion28 Mar 2020
- Study completion28 Mar 2020
Why it stopped: Review of new pre-clinical data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299776
- Sponsor's protocol ID
- 40701
- Status last verified
- Jan 2022
- First submitted
- 2 Mar 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- 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 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Effects of Active Intrathoracic Pressure Regulation Therapy on Hemodynamic Stability During Shoulder Surgery in the Sitting Position
- ClinicalTrials.gov ID
- NCT04299776
- Acronym / sponsor ID
- 40701
- Conditions
- Hypotension on Induction
- Keywords
- Intraoperative hypotension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Review of new pre-clinical data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 9 Mar 2020 (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.
Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications.
The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPR therapy | Experimental | Device: CirQPODIntrathoracic pressure regulation (IPR) therapy level of -10 cmH2O (-7 cmH2O for run-in) provided by the CirQPOD device during shoulder surgery in the sitting position |
| Standard airway | Active comparator | Device: Standard airway managementStandard airway pressure (PEEP of +5 cmH2O) during shoulder surgery in the sitting position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- American Society of Anesthesiologists (ASA) physical status class ≤3
- Scheduled for surgery in sitting/ beach-chair positions under general anesthesia in the Cleveland Clinic main campus
- Planned length of surgery >60 minutes
Key exclusion criteria (9 listed)
- Severe peripheral vascular disease or other contraindication for use of vasopressor infusion
- Obstructive lung disease - moderate or severe asthma or COPD
- Baseline hypoxemia (SpO2<92% on room air)
- Body Mass Index (BMI) >35
- Congestive heart failure
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 |
|---|---|---|
| CirQPODCirQPOD is connected between the wye piece on ventilator/anesthesia machine tubing and the patient's airway and generates negative intrathoracic pressure during the expiratory phase of ventilation which has been shown to improve blood flow. | Device | IPR therapy |
| Standard airway managementStandard airway management during surgery (PEEP of +5 cmH2O) | Device | Standard airway |
Primary outcome
Phenylephrine use
Time frame: from device placement to start of wound closure, a period of up to four hours
Amount of phenylephrine required to maintain MAP of 80±5 mmHg
3 secondary outcomes
Pulmonary artery pressure
Time frame: at least two minutes after IPR level of -10 cmH2O has been set
Atelectasis
Time frame: first day post-op
PaO2
Time frame: at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CirQPOD and Standard airway management in people with Hypotension on Induction, run by Zoll Medical Corporation 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 9 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: withdrawn, as of the sponsor's last update on 27 Jan 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 was withdrawn before enrolling participants, so there are no results.
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?
Phenylephrine use (time frame: from device placement to start of wound closure, a period of up to four hours). 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 27 Jan 2022.