Hypotension on InductionHI-CAPNCT06316817
FloPatch for Prevention of Hypotension After Induction of General Anesthesia
An observational study of Hypotension on Induction, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. 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?
- FloPatch
- Type of treatment
- Medical device
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 26 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are adult patients undergoing elective noncardiac surgery at Mount Sinai Hospital in Toronto, Canada.
Who may be able to join
- Adult patients ≥ 18 years
- Undergoing elective noncardiac under general anesthesia
Who cannot join
- Hypotension, defined as Mean Arterial Pressure (MAP) below 65 mmHg preoperatively on the day of surgery.
- Treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
- Patients with heart failure with ejection fraction (EF) < 40%.
- A history of any previous neck surgery or trauma.
- Cardiac rhythm other than sinus at the time of common carotid artery corrected Flow Time (cFT) assessment.
- Patients who will receive neuraxial blockade (epidural or spinal) performed before induction of general anesthesia.
- Planned placement of a jugular central venous catheter or surgery to be performed in the area of the FloPatch.
- Patient is pregnant or is undergoing obstetrical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Hypotension After Induction of General Anesthesia Using Wearable Carotid Artery Doppler Ultrasound Patch in Adult Patients Undergoing Elective Noncardiac Surgery: a Prospective Observational Study
This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. The investigators will be testing this in adults who are having elective non-heart surgery. Basically, the goal is to see if this device can help predict who might have low blood pressure during surgery.
Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury. Myocardial injury after non-cardiac surgery (MINS) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development.
Read more
In the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. For surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. Optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. Since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it.
The hypothesis is that the corrected Flow Time (cFT) measured by the FloPatch will help predict hypotension after the induction of general anesthesia.
- Conditions
- Hypotension on Induction
- Being tested
- FloPatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloPatchDevice
A novel, hands-free ultrasound patch for continuous monitoring of quantitative Doppler in the carotid artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH).
The primary outcome is the performance characteristics of the preoperative common carotid artery corrected Flow Time (cFT) to predict Post Induction Hypotension(PIH). PIH will be defined as MAP below an absolute threshold of 65 mmHg or relative threshold of 25% decrease from baseline4 (defined as the first preoperative blood pressure measurement on the morning of surgery), within 20 minutes after induction.
Measured: within 20 minutes after induction
Secondary outcomes (5)
Passive leg raising (PLR) in predicting Post Induction Hypotension(PIH).
To determine the ability of the change in common carotid artery corrected Flow Time(cFT) during passive leg raising (PLR) and after PLR in predicting Post Induction Hypotension(PIH).
Measured: The duration of the surgery
Thresholds of common carotid artery corrected Flow Time (cFT) change during Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH).
To determine the optimal thresholds for a preoperative common carotid artery corrected Flow Time (cFT) change during PLR, in predicting Post Induction Hypotension(PIH).
Measured: The duration of the surgery.
Thresholds of common carotid artery corrected Flow Time (cFT) change after Passive Leg Raising(PLR) in predicting Post Induction Hypotension (PIH).
To determine the optimal thresholds for a preoperative common carotid artery corrected Flow Time(cFT), after Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH).
Measured: The duration of the surgery.
Time required to get common carotid artery corrected Flow Time(cFT) data.
To assess the time required to acquire preoperative common carotid artery corrected Flow Time(cFT) data in patients presenting to surgery.
Measured: The duration of the surgery.
Common carotid artery corrected Flow Time (cFT) during induction correlation with Post Induction Hypotension(PIH).
To determine if common carotid artery corrected Flow Time(cFT) measurements taken during the time of anesthetic induction correlate with the occurrence of Post Induction Hypotension(PIH).
Measured: The duration of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Khan, MD, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316817
- Sponsor's protocol ID
- 23-0184-E
- Acronym
- HI-CAP
- Status last verified
- May 2025
- First submitted
- 27 Feb 2024
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension After Induction of General Anesthesia Using Wearable Carotid Artery Doppler Ultrasound Patch in Adult Patients Undergoing Elective Noncardiac Surgery: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06316817
- Acronym / sponsor ID
- HI-CAP / 23-0184-E
- Conditions
- Hypotension on Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 18 Mar 2024 (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.
This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. The investigators will be testing this in adults who are having elective non-heart surgery. Basically, the goal is to see if this device can help predict who might have low blood pressure during surgery.
Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury. Myocardial injury after non-cardiac surgery (MINS) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development.
In the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. For surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. Optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. Since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it.
The hypothesis is that the corrected Flow Time (cFT) measured by the FloPatch will help predict hypotension after the induction of general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are adult patients undergoing elective noncardiac surgery at Mount Sinai Hospital in Toronto, Canada.
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years
- Undergoing elective noncardiac under general anesthesia
Key exclusion criteria (8 listed)
- Hypotension, defined as Mean Arterial Pressure (MAP) below 65 mmHg preoperatively on the day of surgery.
- Treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
- Patients with heart failure with ejection fraction (EF) < 40%.
- A history of any previous neck surgery or trauma.
- Cardiac rhythm other than sinus at the time of common carotid artery corrected Flow Time (cFT) assessment.
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 |
|---|---|---|
| FloPatchA novel, hands-free ultrasound patch for continuous monitoring of quantitative Doppler in the carotid artery. | Device | – |
Primary outcome
Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH).
Time frame: within 20 minutes after induction
The primary outcome is the performance characteristics of the preoperative common carotid artery corrected Flow Time (cFT) to predict Post Induction Hypotension(PIH). PIH will be defined as MAP below an absolute threshold of 65 mmHg or relative threshold of 25% decrease from baseline4 (defined as the first preoperative blood pressure measurement on the morning of surgery), within 20 minutes after induction.
5 secondary outcomes
Passive leg raising (PLR) in predicting Post Induction Hypotension(PIH).
Time frame: The duration of the surgery
Thresholds of common carotid artery corrected Flow Time (cFT) change during Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH).
Time frame: The duration of the surgery.
Thresholds of common carotid artery corrected Flow Time (cFT) change after Passive Leg Raising(PLR) in predicting Post Induction Hypotension (PIH).
Time frame: The duration of the surgery.
Time required to get common carotid artery corrected Flow Time(cFT) data.
Time frame: The duration of the surgery.
Common carotid artery corrected Flow Time (cFT) during induction correlation with Post Induction Hypotension(PIH).
Time frame: The duration of the surgery.
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 5 Jun 2025.
- Individual participant dataSharing planned: No
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Anesthesia
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.
James Khan, MD principal investigator
Staff Anesthesiologist
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 Hypotension on Induction, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 2 inclusion and 8 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 5 Jun 2025. 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 Canada. 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?
Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH). (time frame: within 20 minutes after induction). 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 5 Jun 2025.