Post-spinal HypotensionIP-HYPONCT06769750
Variability of Perfusion Index to Predict Hypotension
A study testing leg-lift maneuver in people with Post-spinal Hypotension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
About one-third of deliveries are performed by cesarean section, and this rate is increasing. The standard anesthetic technique for this procedure is spinal anesthesia (SA), which is associated with hypotension in nearly 70% of cases . Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Post-spinal Hypotension
- What is being tested?
- leg-lift maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jun 2025to 15 Dec 2025
- 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 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient women
- With a term of more than 34 weeks' amenorrhea (SA)
- Requiring a scheduled caesarean section under spinal anaesthesia at the maternity ward of the Hôpital Nord de Marseille (AP-HM).
- Patients affiliated to a Social Security System
Who cannot join
- Urgent caesarean section
- Contraindication to perimedullary anesthesia
- Clinical features likely to distort the plethysmographic signal: scleroderma, Raynaud's syndrome, nail pathology, etc.
- Presence of anti-hypertensive treatment
- Cardiac arrhythmia
- Anesthetist not trained in transthoracic cardiac echography
Show all 9Show fewer
- Refusal to participate in the study
- Guardianship or curatorship, safeguard of justice
- Instable Perfusion Index Signal
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Anesthesia and Intensive Care, Perioperative Medicine, Hôpital Nord,
Marseille, Marseilles, 13000
Hôpital Nord
Marseille, 13000
About this study
Official title: Is the Variability of the Perfusion Index Predictive of Post-spinal Hypotension in Parturients Undergoing Scheduled Cesarean Section
About one-third of deliveries are performed by cesarean section, and this rate is increasing. The standard anesthetic technique for this procedure is spinal anesthesia (SA), which is associated with hypotension in nearly 70% of cases . The mechanism is a sympatholysis leading to a drop in systemic vascular resistance and cardiac output, which can be aggravated by relative hypovolemia. This hypotension is responsible for maternal dizziness, nausea, and vomiting, as well as fetal acidosis, and in extreme cases, fetal circulatory insufficiency.
Currently, it is recommended to prevent post-spinal hypotension through a strategy combining co-loading with fluids and the administration of vasopressors in all patients. However, this non-individualized strategy is not always effective in preventing hypotension and may even be harmful to the mother in cases of excessive fluid administration.
Read more
Current guidelines for perioperative fluid management in elective surgery advocate for an individualized approach based on preoperative assessment of preload dependence through cardiac output monitoring. Correcting this relative hypovolemia helps maintain an appropriate blood pressure for the patient's needs.
In parturients, we have shown that evaluating preload dependence by measuring the variation in the time-velocity integral under the aorta (ΔTVI) using cardiac ultrasound before and after a passive leg raising test (PLR) can predict post-spinal hypotension with good sensitivity and specificity. We obtained comparable results using monitoring of the variation in stroke volume by the Clearsight™ system (Edwards Lifesciences, Irvine, California, US), before and after PLR .
However, these technologies have limitations: availability of equipment, cost, operator expertise, and patient echogenicity in the case of ultrasound. Using a non-invasive, simple, and accessible method for monitoring preload dependence that can be used by an untrained operator would help easily identify patients at higher risk for post-spinal hypotension, enabling individualized management.
The main objective of our study is to evaluate the ability of ΔIPELJP to predict post-rachianesthesia hypotension in parturients scheduled for a cesarean section.
Read the detailed description
This is a prospective, monocentric study carried out at the level 3 maternity unit of Marseille's Hôpital Nord Patients will be monitored as usual using an SpO2 sensor placed on the index finger of the limb contralateral to the blood pressure cuff, giving the PI value, a blood pressure monitor taking blood pressure (systolic, diastolic and mean) every 2 minutes, and an ECG.
A transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be taken 1 min after a passive leg-lift to see whether this maneuver significantly increases systolic ejection volume. The PI value and arterial pressure will be measured at each of these manoeuvres. The same data will be collected one minute after return to the initial position. Thereafter, PI and arterial pressure will be recorded every two minutes until the newborn is delivered.
The pH of the newborn's cord blood is systematically recorded.
- Conditions
- Post-spinal Hypotension
- Being tested
- leg-lift maneuver
- Keywords
- Spinal anesthesia, Scheduled caesarean section, Parturientes, Post-anaesthetic hypotension, Hypotension prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg-lift maneuverOther
Patients will be monitored as usual using an SpO2 sensor placed on the index finger of the limb contralateral to the pressure cuff, giving the PI value, a tensiometer taking blood pressure (systolic, diastolic and mean) every 2 minutes, and an ECG.
A transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be performed 1 min after a passive leg-lift to see if this maneuver significantly increases systolic ejection volume. The PI value and blood pressure will be measured at each of these maneuvers.
leg-lift maneuverOther
The perfusion index (PI) value and arterial pressure will be measured at each of manoeuvre
| Study group | Role | What they receive |
|---|---|---|
| passive leg-lift | Experimental | A transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be performed 1 min after a passive leg-lift to see if this maneuver significantly increases systolic ejection volume. The perfusion index (PI) value and arterial pressure will be measured at each of these manoeuvres. The same data will be collected one minute after return to the initial position. Thereafter, PI and arterial pressure will be recorded every two minutes until the newborn is delivered. Receives: Other: leg-lift maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔIPELJP
This value will be calculated by subtracting the PI one minute after the passive leg lift from the resting value measured one minute before he passive leg lift was performed.
Measured: at the time of cesarean section
Secondary outcomes (7)
Incidence of hypotension after rachianesthesia
Defined as a fall in systolic blood pressure of more than 20% between the resting value before lifting the passive leg and the performance of rachi anesthesia, until delivery of the newborn.
Measured: At the time of cesarean delivery
- The delta of PI between PI before spinal anaesthesia and minimum and maximum PI values after spinal anaesthesia and until delivery of the newborn,
PI will be recorded every minute.
Measured: At the time of cesarean delivery
The correlation between ΔIPELJP and ΔITVELJP
Measured: Before spinal anaesthesia
Relationship between basal PI and ΔIPELJP to individualize groups at risk of developing hypotension
Measured: At the time of cesarean delivery
Correlation between fetal pH value at cord and relationship with initial PI value, PI variation and ΔITVELJP
Measured: At delivery
Maximum doses of norepinephrine in mg/h from the time of rachi anesthesia to delivery of the neonate
Measured: At delivery
-Cumulative doses of noradrenaline in mg from rachi anesthesia to neonatal delivery
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Jun 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769750
- Sponsor's protocol ID
- APHP240165
- Acronym
- IP-HYPO
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruscagnin C, Shi R, Rosalba D, Fouque G, Hagry J, Lai C, Donadello K, Pham T, Teboul JL, Monnet X. Testing preload responsiveness by the tidal volume challenge assessed by the photoplethysmographic perfusion index. Crit Care. 2024 Sep 16;28(1):305. doi: 10.1186/s13054-024-05085-w.
PubMed 39285430Duclos G, Granier S, Hili A, Blanc J, Einav S, Leone M, Zieleskiewicz L. Performance of non-invasive stroke volume variation during passive leg raising as a predictor of hypotension following induction of spinal anesthesia for elective cesarean delivery: a single cohort study. Int J Obstet Anesth. 2022 May;50:103251. doi: 10.1016/j.ijoa.2021.103251. Epub 2021 Dec 30.
PubMed 35074676Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
PubMed 28890560Beurton A, Gavelli F, Teboul JL, De Vita N, Monnet X. Changes in the Plethysmographic Perfusion Index During an End-Expiratory Occlusion Detect a Positive Passive Leg Raising Test. Crit Care Med. 2021 Feb 1;49(2):e151-e160. doi: 10.1097/CCM.0000000000004768.
PubMed 33332814Toyama S, Kakumoto M, Morioka M, Matsuoka K, Omatsu H, Tagaito Y, Numai T, Shimoyama M. Perfusion index derived from a pulse oximeter can predict the incidence of hypotension during spinal anaesthesia for Caesarean delivery. Br J Anaesth. 2013 Aug;111(2):235-41. doi: 10.1093/bja/aet058. Epub 2013 Mar 21.
PubMed 23518802
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Variability of the Perfusion Index Predictive of Post-spinal Hypotension in Parturients Undergoing Scheduled Cesarean Section
- ClinicalTrials.gov ID
- NCT06769750
- Acronym / sponsor ID
- IP-HYPO / APHP240165
- Conditions
- Post-spinal Hypotension
- Keywords
- Spinal anesthesia, Scheduled caesarean section, Parturientes, Post-anaesthetic hypotension, Hypotension prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 10 Jan 2025 (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.
About one-third of deliveries are performed by cesarean section, and this rate is increasing. The standard anesthetic technique for this procedure is spinal anesthesia (SA), which is associated with hypotension in nearly 70% of cases . The mechanism is a sympatholysis leading to a drop in systemic vascular resistance and cardiac output, which can be aggravated by relative hypovolemia. This hypotension is responsible for maternal dizziness, nausea, and vomiting, as well as fetal acidosis, and in extreme cases, fetal circulatory insufficiency.
Currently, it is recommended to prevent post-spinal hypotension through a strategy combining co-loading with fluids and the administration of vasopressors in all patients. However, this non-individualized strategy is not always effective in preventing hypotension and may even be harmful to the mother in cases of excessive fluid administration.
Current guidelines for perioperative fluid management in elective surgery advocate for an individualized approach based on preoperative assessment of preload dependence through cardiac output monitoring. Correcting this relative hypovolemia helps maintain an appropriate blood pressure for the patient's needs.
In parturients, we have shown that evaluating preload dependence by measuring the variation in the time-velocity integral under the aorta (ΔTVI) using cardiac ultrasound before and after a passive leg raising test (PLR) can predict post-spinal hypotension with good sensitivity and specificity. We obtained comparable results using monitoring of the variation in stroke volume by the Clearsight™ system (Edwards Lifesciences, Irvine, California, US), before and after PLR .
However, these technologies have limitations: availability of equipment, cost, operator expertise, and patient echogenicity in the case of ultrasound. Using a non-invasive, simple, and accessible method for monitoring preload dependence that can be used by an untrained operator would help easily identify patients at higher risk for post-spinal hypotension, enabling individualized management.
The main objective of our study is to evaluate the ability of ΔIPELJP to predict post-rachianesthesia hypotension in parturients scheduled for a cesarean section.
Detailed description
This is a prospective, monocentric study carried out at the level 3 maternity unit of Marseille's Hôpital Nord Patients will be monitored as usual using an SpO2 sensor placed on the index finger of the limb contralateral to the blood pressure cuff, giving the PI value, a blood pressure monitor taking blood pressure (systolic, diastolic and mean) every 2 minutes, and an ECG.
A transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be taken 1 min after a passive leg-lift to see whether this maneuver significantly increases systolic ejection volume. The PI value and arterial pressure will be measured at each of these manoeuvres. The same data will be collected one minute after return to the initial position. Thereafter, PI and arterial pressure will be recorded every two minutes until the newborn is delivered.
The pH of the newborn's cord blood is systematically recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| passive leg-lift | Experimental | Other: leg-lift maneuverA transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be performed 1 min after a passive leg-lift to see if this maneuver significantly increases systolic ejection volume. The perfusion index (PI) value and arterial pressure will be measured at each of these manoeuvres. The same data will be collected one minute after return to the initial position. Thereafter, PI and arterial pressure will be recorded every two minutes until the newborn is delivered. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturient women
- With a term of more than 34 weeks' amenorrhea (SA)
- Requiring a scheduled caesarean section under spinal anaesthesia at the maternity ward of the Hôpital Nord de Marseille (AP-HM).
- Patients affiliated to a Social Security System
Key exclusion criteria (9 listed)
- Urgent caesarean section
- Contraindication to perimedullary anesthesia
- Clinical features likely to distort the plethysmographic signal: scleroderma, Raynaud's syndrome, nail pathology, etc.
- Presence of anti-hypertensive treatment
- Cardiac arrhythmia
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 |
|---|---|---|
| leg-lift maneuverPatients will be monitored as usual using an SpO2 sensor placed on the index finger of the limb contralateral to the pressure cuff, giving the PI value, a tensiometer taking blood pressure (systolic, diastolic and mean) every 2 minutes, and an ECG. A transthoracic cardiac echocardiogram will be performed with measurement of the sub-aortic time-velocity integral, and the same measurement will be performed 1 min after a passive leg-lift to see if this maneuver significantly increases systolic ejection volume. The PI value and blood pressure will be measured at each of these maneuvers. | Other | passive leg-lift |
| leg-lift maneuverThe perfusion index (PI) value and arterial pressure will be measured at each of manoeuvre | Other | passive leg-lift |
Primary outcome
ΔIPELJP
Time frame: at the time of cesarean section
This value will be calculated by subtracting the PI one minute after the passive leg lift from the resting value measured one minute before he passive leg lift was performed.
7 secondary outcomes
Incidence of hypotension after rachianesthesia
Time frame: At the time of cesarean delivery
- The delta of PI between PI before spinal anaesthesia and minimum and maximum PI values after spinal anaesthesia and until delivery of the newborn,
Time frame: At the time of cesarean delivery
The correlation between ΔIPELJP and ΔITVELJP
Time frame: Before spinal anaesthesia
Relationship between basal PI and ΔIPELJP to individualize groups at risk of developing hypotension
Time frame: At the time of cesarean delivery
Correlation between fetal pH value at cord and relationship with initial PI value, PI variation and ΔITVELJP
Time frame: At delivery
Maximum doses of norepinephrine in mg/h from the time of rachi anesthesia to delivery of the neonate
Time frame: At delivery
-Cumulative doses of noradrenaline in mg from rachi anesthesia to neonatal delivery
Time frame: At delivery
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 23 Feb 2026.
- Background: PubMed 39285430Bruscagnin C, Shi R, Rosalba D, Fouque G, Hagry J, Lai C, Donadello K, Pham T, Teboul JL, Monnet X. Testing preload responsiveness by the tidal volume challenge assessed by the photoplethysmographic perfusion index. Crit Care. 2024 Sep 16;28(1):305. doi: 10.1186/s13054-024-05085-w.
- Background: PubMed 35074676Duclos G, Granier S, Hili A, Blanc J, Einav S, Leone M, Zieleskiewicz L. Performance of non-invasive stroke volume variation during passive leg raising as a predictor of hypotension following induction of spinal anesthesia for elective cesarean delivery: a single cohort study. Int J Obstet Anesth. 2022 May;50:103251. doi: 10.1016/j.ijoa.2021.103251. Epub 2021 Dec 30.
- Background: PubMed 28890560Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
- Background: PubMed 33332814Beurton A, Gavelli F, Teboul JL, De Vita N, Monnet X. Changes in the Plethysmographic Perfusion Index During an End-Expiratory Occlusion Detect a Positive Passive Leg Raising Test. Crit Care Med. 2021 Feb 1;49(2):e151-e160. doi: 10.1097/CCM.0000000000004768.
- Background: PubMed 23518802Toyama S, Kakumoto M, Morioka M, Matsuoka K, Omatsu H, Tagaito Y, Numai T, Shimoyama M. Perfusion index derived from a pulse oximeter can predict the incidence of hypotension during spinal anaesthesia for Caesarean delivery. Br J Anaesth. 2013 Aug;111(2):235-41. doi: 10.1093/bja/aet058. Epub 2013 Mar 21.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg-lift maneuver in people with Post-spinal Hypotension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
ΔIPELJP (time frame: at the time of cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769750, which also lists 5 linked publications.
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 23 Feb 2026.