Intraoperative HypotensionNCT05237856
The Use of Integrated Pulmonary Index During Cesarean Section Under Spinal Anesthesia
An observational study of Intraoperative Hypotension, run by Selcuk University.
Trial summary
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that can result in organ hypoperfusion and ischemic events. In pregnant patients, this incidence may increase to 70% and severe PSH increases the risk of maternal and fetal complications. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Capnometry Monitorization
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Nov 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnants above the age of 18 who will undergo cesarean section under spinal anesthesia
Who may be able to join
- ASA I-II pregnants who will undergo cesarean section under spinal anesthesia
Who cannot join
- ASA III- IV Pregnants.
- Pregnants with chronic respiratory disorder.
- Pregnants who will undergo cesarean section under emergency conditions.
About this study
Official title: The Use of End Tidal CO2 and Integrated Pulmonary Index to Predict Post Spinal Hypotension in Cesarean Section
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that can result in organ hypoperfusion and ischemic events. In pregnant patients, this incidence may increase to 70% and severe PSH increases the risk of maternal and fetal complications. Therefore, it is extremely important for anesthesiologists to recognize PSH early and treat it quickly during cesarean sections.
Integrated pulmonary index (IPI) is an algorithm that has been used recently. IPI takes into account four parameters: respiratory rate, end tidal CO2, heart rate and O2 saturation. Capnography device measuring IPI can continuously monitor and display the patient's respiratory status in a single digit range from 1-10. This index value can be observed continuously on the monitor as digital data or as a waveform. "10" indicates a normal respiratory condition, while "1" indicates that the patient requires immediate intervention. The relationship between values and the patient status is evaluated as follows; 10 = Normal, 8-9 = Normal range, 7 = Near normal range; Requires attention, 5-6 = Requires attention and may require intervention, 3-4 = Requires intervention, 1-2 = Requires immediate intervention.
Read more
IPI monitorization is mostly used during sedation (gastroscopy, cardioversion), intensive care units (for adjusting mechanical ventilator settings, monitoring the weaning process).
As a result, IPI monitoring has attracted attention because it allows non-invasive, dynamic and real-time measurement, reflects respiratory status with high specificity and sensitivity, and enables respiratory problems to be detected earlier.
End tidal CO2, which is one of the 4 parameters that IPI value takes into account, is a parameter that can be used to evaluate the effectiveness of ventilation, but is also related to cardiac output (CO) because the delivery of CO2 to the pulmonary system depends on it. Studies have shown that ETCO2 value correlatively decreases when CO decrease, in cases such as hypotension and hypovolemia.
We think that ETCO2 will decrease due to pulmonary hypoperfusion in post spinal hypotension and it may cause a change in IPI value. In our study, we will monitor patients who are scheduled for cesarean section under spinal anesthesia with a capnometry device and we will try to determine the significance of IPI monitorization in predicting hypotension.
Read the detailed description
Patients who underwent cesarean section under spinal anesthesia and who agreed to participate in the study will be included in the study.
Demographic data of the patients (age, gender, weight, concomitant diseases, etc.) will be recorded.
After spinal anesthesia, a non-invasive nasal cannula will be inserted into the patients, and ETCO2 and IPI values will be continuously measured and recorded from this cannula with a capnometry device.
As is routinely done, blood pressure will be measured at 2-minute intervals after spinal anesthesia is administered.
The non-invasive blood pressure value measured before spinal anesthesia will be taken as the baseline value, and a decrease of 20% or more in this value or a decrease in systolic blood pressure below 100 mmHg will be considered hypotension.
The correlation between the developing hypotension and the End tidal CO2 and IPI measurements will be examined.
- Conditions
- Intraoperative Hypotension
- Being tested
- Capnometry Monitorization
- Keywords
- cesarean, hypotension, ETCO2, integrated pulmonary index
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnometry MonitorizationDevice
After spinal anesthesia, a non-invasive nasal cannula will be applied to the patient, ETCO2 and IPI values will be continuously measured and recorded from this cannula with a capnometry device.
What is being measured
The primary outcome is the main question the study is designed to answer.
noninvasive blood pressure
hypotension:20% reduction in basal blood pressure measurement,
Measured: 20 minutes
Integrated pulmoner index (IPI)
requires intervention: IPI value < 7,
Measured: 20 minutes
end-tidal carbon dioxide (ETCO2)
hypoperfusion: ETCO2 value < 35 mmHg
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE ASLANLAR, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237856
- Sponsor's protocol ID
- IPI
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of End Tidal CO2 and Integrated Pulmonary Index to Predict Post Spinal Hypotension in Cesarean Section
- ClinicalTrials.gov ID
- NCT05237856
- Acronym / sponsor ID
- IPI
- Conditions
- Intraoperative Hypotension
- Keywords
- cesarean, hypotension, ETCO2, integrated pulmonary index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 14 Feb 2022 (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.
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that can result in organ hypoperfusion and ischemic events. In pregnant patients, this incidence may increase to 70% and severe PSH increases the risk of maternal and fetal complications. Therefore, it is extremely important for anesthesiologists to recognize PSH early and treat it quickly during cesarean sections.
Integrated pulmonary index (IPI) is an algorithm that has been used recently. IPI takes into account four parameters: respiratory rate, end tidal CO2, heart rate and O2 saturation. Capnography device measuring IPI can continuously monitor and display the patient's respiratory status in a single digit range from 1-10. This index value can be observed continuously on the monitor as digital data or as a waveform. "10" indicates a normal respiratory condition, while "1" indicates that the patient requires immediate intervention. The relationship between values and the patient status is evaluated as follows; 10 = Normal, 8-9 = Normal range, 7 = Near normal range; Requires attention, 5-6 = Requires attention and may require intervention, 3-4 = Requires intervention, 1-2 = Requires immediate intervention.
IPI monitorization is mostly used during sedation (gastroscopy, cardioversion), intensive care units (for adjusting mechanical ventilator settings, monitoring the weaning process).
As a result, IPI monitoring has attracted attention because it allows non-invasive, dynamic and real-time measurement, reflects respiratory status with high specificity and sensitivity, and enables respiratory problems to be detected earlier.
End tidal CO2, which is one of the 4 parameters that IPI value takes into account, is a parameter that can be used to evaluate the effectiveness of ventilation, but is also related to cardiac output (CO) because the delivery of CO2 to the pulmonary system depends on it. Studies have shown that ETCO2 value correlatively decreases when CO decrease, in cases such as hypotension and hypovolemia.
We think that ETCO2 will decrease due to pulmonary hypoperfusion in post spinal hypotension and it may cause a change in IPI value. In our study, we will monitor patients who are scheduled for cesarean section under spinal anesthesia with a capnometry device and we will try to determine the significance of IPI monitorization in predicting hypotension.
Detailed description
Patients who underwent cesarean section under spinal anesthesia and who agreed to participate in the study will be included in the study.
Demographic data of the patients (age, gender, weight, concomitant diseases, etc.) will be recorded.
After spinal anesthesia, a non-invasive nasal cannula will be inserted into the patients, and ETCO2 and IPI values will be continuously measured and recorded from this cannula with a capnometry device.
As is routinely done, blood pressure will be measured at 2-minute intervals after spinal anesthesia is administered.
The non-invasive blood pressure value measured before spinal anesthesia will be taken as the baseline value, and a decrease of 20% or more in this value or a decrease in systolic blood pressure below 100 mmHg will be considered hypotension.
The correlation between the developing hypotension and the End tidal CO2 and IPI measurements will be examined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnants above the age of 18 who will undergo cesarean section under spinal anesthesia
Key inclusion criteria (1 listed)
- ASA I-II pregnants who will undergo cesarean section under spinal anesthesia
Key exclusion criteria (3 listed)
- ASA III- IV Pregnants.
- Pregnants with chronic respiratory disorder.
- Pregnants who will undergo cesarean section under emergency conditions.
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 |
|---|---|---|
| Capnometry MonitorizationAfter spinal anesthesia, a non-invasive nasal cannula will be applied to the patient, ETCO2 and IPI values will be continuously measured and recorded from this cannula with a capnometry device. | Device | – |
Primary outcome
noninvasive blood pressure
Time frame: 20 minutes
hypotension:20% reduction in basal blood pressure measurement,
Integrated pulmoner index (IPI)
Time frame: 20 minutes
requires intervention: IPI value < 7,
end-tidal carbon dioxide (ETCO2)
Time frame: 20 minutes
hypoperfusion: ETCO2 value < 35 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Hypotension, run by Selcuk University.
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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
noninvasive blood pressure (time frame: 20 minutes). The study lists 3 primary outcomes in all. 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 14 Feb 2022.