Post-induction Hypotension (PIH)NCT07876362
Preoperative Caval-Aortic Index and Pleth Variability Index for Predicting Post-Induction Hypotension in Colorectal Surgery
An observational study of Post-induction Hypotension (PIH), run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated whether the preoperative caval-aortic index and pleth variability index can predict post-induction hypotension in adult patients undergoing elective colorectal surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-induction Hypotension (PIH)
- What is being tested?
- Preoperative Caval-Aortic Index and Pleth Variability Index Assessment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jan 2026
- 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: Adult patients aged 18 years or older with ASA physical status I-III who were scheduled for elective colorectal surgery at a single tertiary-care center, underwent preoperative bowel preparation, and had completed at least 8 hours of fasting. Eligible patients who agreed to participate and provided written informed consent were enrolled consecutively during the study period.
Who may be able to join
- Age 18 years or older
- ASA physical status I-III
- Scheduled for elective colorectal surgery
- Underwent preoperative bowel preparation
- Preoperative fasting duration of at least 8 hours
- Provided written informed consent
Who cannot join
- Refusal to participate
- Chronic kidney failure or liver failure
- Pregnancy
- Body mass index >35 kg/m²
- Left ventricular ejection fraction <40%
- Pulmonary hypertension or right ventricular failure
Show all 12Show fewer
- Abdominal aortic aneurysm
- Increased intra-abdominal pressure
- Known arrhythmia or active arrhythmia detected during preoperative evaluation
- Preoperative systolic blood pressure <90 mmHg or mean arterial pressure <60 mmHg
- Anticipated difficult airway expected to interfere with the standardized induction and intubation process
- Inadequate ultrasonographic visualization of the inferior vena cava or abdominal aorta, preventing reliable diameter measurement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kirdar City Hospital
Istanbul, Istanbul
About this study
Official title: Predictive Value of the Preoperative Caval-Aortic Index and Pleth Variability Index for Post-Induction Hypotension in Patients Undergoing Elective Colorectal Surgery
This prospective observational study evaluated whether the preoperative caval-aortic index and pleth variability index can predict post-induction hypotension in adult patients undergoing elective colorectal surgery under general anesthesia. Preoperative caval-aortic index and pleth variability index values were recorded before anesthesia induction. Blood pressure was measured before induction and at 1, 3, 5, 7, and 10 minutes after induction. Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg. The predictive performance of the preoperative caval-aortic index and pleth variability index for post-induction hypotension was assessed.
Read the detailed description
This prospective observational study included adult patients scheduled for elective colorectal surgery under general anesthesia. Before induction of anesthesia, intravascular volume status was assessed using the caval-aortic index obtained by ultrasonographic measurement of the inferior vena cava and aortic diameters, and by the pleth variability index obtained from pulse oximetry-derived monitoring. Baseline noninvasive systolic, diastolic, and mean arterial blood pressure values were recorded before induction. After induction of general anesthesia, noninvasive blood pressure measurements were recorded at 1, 3, 5, 7, and 10 minutes. Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg at any of these time points. The primary objective was to evaluate the predictive performance of the preoperative caval-aortic index and pleth variability index for post-induction hypotension. Associations with demographic and perioperative variables were also assessed. Receiver operating characteristic curve analysis was used to evaluate discriminatory performance and determine optimal cut-off values for the caval-aortic index and pleth variability index.
- Conditions
- Post-induction Hypotension (PIH)
- Being tested
- Preoperative Caval-Aortic Index and Pleth Variability Index Assessment
- Keywords
- Caval-Aortic Index, Pleth Variability Index, Post-Induction Hypotension, General Anesthesia, Colorectal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Caval-Aortic Index and Pleth Variability Index AssessmentOther
Preoperative caval-aortic index was calculated from ultrasonographic measurements of the inferior vena cava and abdominal aorta, and Pleth Variability Index was recorded before induction of general anesthesia. These measurements did not alter routine anesthetic management.
| Study group | Role | What they receive |
|---|---|---|
| Elective Colorectal Surgery Patients | Adult patients undergoing elective colorectal surgery under general anesthesia who underwent preoperative caval-aortic index and pleth variability index assessment. Receives: Other: Preoperative Caval-Aortic Index and Pleth Variability Index Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Post-Induction Hypotension
Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg at any of the blood pressure measurements obtained after induction of general anesthesia.
Measured: Within the first 10 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-induction Hypotension (PIH)Studies 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmet Can Altun, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876362
- Sponsor's protocol ID
- 2024/21/979
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Preoperative Caval-Aortic Index and Pleth Variability Index for Post-Induction Hypotension in Patients Undergoing Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07876362
- Acronym / sponsor ID
- 2024/21/979
- Conditions
- Post-induction Hypotension (PIH)
- Keywords
- Caval-Aortic Index, Pleth Variability Index, Post-Induction Hypotension, General Anesthesia, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 Oct 2026 (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 prospective observational study evaluated whether the preoperative caval-aortic index and pleth variability index can predict post-induction hypotension in adult patients undergoing elective colorectal surgery under general anesthesia. Preoperative caval-aortic index and pleth variability index values were recorded before anesthesia induction. Blood pressure was measured before induction and at 1, 3, 5, 7, and 10 minutes after induction. Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg. The predictive performance of the preoperative caval-aortic index and pleth variability index for post-induction hypotension was assessed.
Detailed description
This prospective observational study included adult patients scheduled for elective colorectal surgery under general anesthesia. Before induction of anesthesia, intravascular volume status was assessed using the caval-aortic index obtained by ultrasonographic measurement of the inferior vena cava and aortic diameters, and by the pleth variability index obtained from pulse oximetry-derived monitoring. Baseline noninvasive systolic, diastolic, and mean arterial blood pressure values were recorded before induction. After induction of general anesthesia, noninvasive blood pressure measurements were recorded at 1, 3, 5, 7, and 10 minutes. Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg at any of these time points. The primary objective was to evaluate the predictive performance of the preoperative caval-aortic index and pleth variability index for post-induction hypotension. Associations with demographic and perioperative variables were also assessed. Receiver operating characteristic curve analysis was used to evaluate discriminatory performance and determine optimal cut-off values for the caval-aortic index and pleth variability index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Colorectal Surgery Patients | – | Other: Preoperative Caval-Aortic Index and Pleth Variability Index AssessmentAdult patients undergoing elective colorectal surgery under general anesthesia who underwent preoperative caval-aortic index and pleth variability index assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older with ASA physical status I-III who were scheduled for elective colorectal surgery at a single tertiary-care center, underwent preoperative bowel preparation, and had completed at least 8 hours of fasting. Eligible patients who agreed to participate and provided written informed consent were enrolled consecutively during the study period.
Key inclusion criteria (6 listed)
- Age 18 years or older
- ASA physical status I-III
- Scheduled for elective colorectal surgery
- Underwent preoperative bowel preparation
- Preoperative fasting duration of at least 8 hours
Key exclusion criteria (12 listed)
- Refusal to participate
- Chronic kidney failure or liver failure
- Pregnancy
- Body mass index >35 kg/m²
- Left ventricular ejection fraction <40%
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 |
|---|---|---|
| Preoperative Caval-Aortic Index and Pleth Variability Index AssessmentPreoperative caval-aortic index was calculated from ultrasonographic measurements of the inferior vena cava and abdominal aorta, and Pleth Variability Index was recorded before induction of general anesthesia. These measurements did not alter routine anesthetic management. | Other | Elective Colorectal Surgery Patients |
Primary outcome
Occurrence of Post-Induction Hypotension
Time frame: Within the first 10 minutes after induction of general anesthesia
Post-induction hypotension was defined as a decrease in systolic blood pressure of more than 30% from baseline and/or a mean arterial pressure below 60 mmHg at any of the blood pressure measurements obtained after induction of general anesthesia.
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 15 Oct 2026.
- 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.
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?
An observational study of Post-induction Hypotension (PIH), run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 12 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 15 Oct 2026. 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 Turkey (Türkiye). 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?
Occurrence of Post-Induction Hypotension (time frame: Within the first 10 minutes after induction of general anesthesia). 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 15 Oct 2026.