Hypotension Drug-InducedNCT07766967
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
A study testing Alveolar Recruitment Maneuver (ARM) and Passive Leg Raising (PLR) Test in people with Hypotension Drug-Induced and General Anesthesia Using Endotracheal Intubation, run by University of Health Sciences Balikesir Hospital Eduation and Research at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether two simple bedside tests - the Passive Leg Raising (PLR) test and the Pleth Variability Index (PVI) - can predict a drop in blood pressure that sometimes occurs during a lung-opening procedure called an Alveolar Recruitment Maneuver (ARM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation, Atelectasis
- What is being tested?
- Alveolar Recruitment Maneuver (ARM) and Passive Leg Raising (PLR) Test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion Criteria:Age 18 years or older ASA physical status I or II Scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia Able to provide written informed consent -
Exclusion Criteria:Cardiac or thoracic surgery Hemodynamic instability at baseline (MAP <65 mmHg or requirement for vasopressors) Severe valvular heart disease or known cardiac dysfunction (EF <40%) Chronic obstructive pulmonary disease (COPD) or severe respiratory disease Atrial fibrillation or other significant arrhythmias Peripheral vascular disease affecting PVI signal quality Body mass index (BMI) >40 kg/m² Emergency surgery Refusal to participate or inability to provide informed consent Pregnancy
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Balıkesir Atatürk City Hospital
Balıkesir, Altıeylül, 10100
Hasan Duman, 05547317716, hasanduman.1991@gmail.com
About this study
Official title: Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Outcome and Intraoperative Indicator of Fluid Responsiveness
This study investigates whether two simple bedside tests - the Passive Leg Raising (PLR) test and the Pleth Variability Index (PVI) - can predict a drop in blood pressure that sometimes occurs during a lung-opening procedure called an Alveolar Recruitment Maneuver (ARM).
ARM is routinely performed during general anesthesia to prevent lung collapse and improve oxygen levels. However, in some patients - particularly those with low fluid levels - ARM can cause a temporary but significant drop in blood pressure (hypotension), which may require immediate treatment.
Read more
In this prospective observational study, adult patients scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia will be enrolled. Before each ARM is performed, PLR test and PVI values will be measured. We will then evaluate how well these measurements predict whether the patient will develop ARM-induced hypotension.
If PLR and PVI can reliably identify patients at risk, clinicians may be able to take preventive steps before performing ARM, making the procedure safer for vulnerable patients.
- Conditions
- Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation, Atelectasis, Fluid Responsiveness, Mechanical Ventilation
- Being tested
- Alveolar Recruitment Maneuver (ARM), Passive Leg Raising (PLR) Test
- Keywords
- Alveolar Recruitment Maneuver, Passive Leg Raising, Pleth Variability Index, hypotension, Fluid responsiveness, Dynamic preload indicators, Intraoperative monitoring, General anesthesia, Lung-protective ventilation, Perioperative hemodynamics
- Medical subject headings
- Hypotension, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Recruitment Maneuver (ARM)Device
ARM is performed using a stepwise increase in positive end-expiratory pressure (PEEP) in pressure-controlled ventilation mode until peak inspiratory pressure reaches 40 cmH₂O, then stepwise decrease back to baseline. Hemodynamic parameters are continuously monitored throughout the maneuver.
Passive Leg Raising (PLR) TestBehavioural
With the patient in supine position under general anesthesia, both legs are raised to 45 degrees for 60 seconds. The change in mean arterial pressure (ΔMAP) is recorded as an indicator of preload responsiveness. The test is performed immediately before each ARM.
| Study group | Role | What they receive |
|---|---|---|
| ARM-Induced Hypotension Prediction Group | Experimental | Adult patients scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia. Before each alveolar recruitment maneuver (ARM), a passive leg raising (PLR) test is performed and pleth variability index (PVI) is recorded. Blood pressure changes during ARM are monitored to evaluate whether pre-ARM PLR and PVI values can predict ARM-induced hypotension. Receives: Device: Alveolar Recruitment Maneuver (ARM); Behavioral: Passive Leg Raising (PLR) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of ARM-Induced Hypotension by PLR Test and PVI
Area under the ROC curve (AUC) of pre-ARM passive leg raising test (PLR-ΔMAP) for predicting ARM-induced hypotension (defined as MAP decrease ≥20% from baseline or MAP <65 mmHg during ARM).
Measured: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.
AUC of PVI for Predicting ARM-Induced Hypotension
Area under the ROC curve (AUC) of pre-ARM pleth variability index (PVI) for predicting ARM-induced hypotension (defined as MAP decrease ≥20% from baseline or MAP <65 mmHg during ARM)
Measured: Measured continuously from induction of general anesthesia until completion of the alveolar recruitment maneuver, assessed intraoperatively.
Secondary outcomes (2)
Correlation Between ARM-Induced ΔMAP% and Post-ARM Fluid Responsiveness
Pearson or Spearman correlation coefficient between the maximum MAP decrease during ARM (ΔMAP%) and fluid responsiveness after ARM. Fluid responsiveness is defined as MAP increase ≥10% following 250 mL crystalloid bolus.
Measured: From onset of ARM until 10 minutes after completion of ARM, assessed intraoperatively.
Comparative Diagnostic Accuracy of PLR Test versus PVI for Predicting ARM-Induced Hypotension
The difference in AUC values between PLR-ΔMAP and PVI will be compared using the DeLong method.
Measured: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypotension Drug-InducedStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766967
- Sponsor's protocol ID
- hasanduman3
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desebbe O, Vallier S, Gergele L, Alexander B, Marx A, Ben Jaoude E, Kato H, Toubal L, Berna A, Duranteau J, Vincent JL, Joosten A. Diagnostic accuracy of the peripheral venous pressure variation induced by an alveolar recruitment maneuver to predict fluid responsiveness during high-risk abdominal surgery. BMC Anesthesiol. 2023 Jul 22;23(1):249. doi: 10.1186/s12871-023-02194-x.
PubMed 37481588Doughan A, Adingo W, Salifu SP. RNA-seq research landscape in Africa: systematic review reveals disparities and opportunities. Eur J Med Res. 2023 Jul 22;28(1):244. doi: 10.1186/s40001-023-01206-3.
PubMed 37480073Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
PubMed 26682219
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Outcome and Intraoperative Indicator of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT07766967
- Acronym / sponsor ID
- hasanduman3
- Conditions
- Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation, Atelectasis, Fluid Responsiveness, Mechanical Ventilation
- Keywords
- Alveolar Recruitment Maneuver, Passive Leg Raising, Pleth Variability Index, hypotension, Fluid responsiveness, Dynamic preload indicators, Intraoperative monitoring, General anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 17 Aug 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 study investigates whether two simple bedside tests - the Passive Leg Raising (PLR) test and the Pleth Variability Index (PVI) - can predict a drop in blood pressure that sometimes occurs during a lung-opening procedure called an Alveolar Recruitment Maneuver (ARM).
ARM is routinely performed during general anesthesia to prevent lung collapse and improve oxygen levels. However, in some patients - particularly those with low fluid levels - ARM can cause a temporary but significant drop in blood pressure (hypotension), which may require immediate treatment.
In this prospective observational study, adult patients scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia will be enrolled. Before each ARM is performed, PLR test and PVI values will be measured. We will then evaluate how well these measurements predict whether the patient will develop ARM-induced hypotension.
If PLR and PVI can reliably identify patients at risk, clinicians may be able to take preventive steps before performing ARM, making the procedure safer for vulnerable patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM-Induced Hypotension Prediction Group | Experimental | Device: Alveolar Recruitment Maneuver (ARM), Behavioral: Passive Leg Raising (PLR) TestAdult patients scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia. Before each alveolar recruitment maneuver (ARM), a passive leg raising (PLR) test is performed and pleth variability index (PVI) is recorded. Blood pressure changes during ARM are monitored to evaluate whether pre-ARM PLR and PVI values can predict ARM-induced hypotension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Alveolar Recruitment Maneuver (ARM)ARM is performed using a stepwise increase in positive end-expiratory pressure (PEEP) in pressure-controlled ventilation mode until peak inspiratory pressure reaches 40 cmH₂O, then stepwise decrease back to baseline. Hemodynamic parameters are continuously monitored throughout the maneuver. | Device | ARM-Induced Hypotension Prediction Group |
| Passive Leg Raising (PLR) TestWith the patient in supine position under general anesthesia, both legs are raised to 45 degrees for 60 seconds. The change in mean arterial pressure (ΔMAP) is recorded as an indicator of preload responsiveness. The test is performed immediately before each ARM. | Behavioural | ARM-Induced Hypotension Prediction Group |
Primary outcome
Prediction of ARM-Induced Hypotension by PLR Test and PVI
Time frame: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.
Area under the ROC curve (AUC) of pre-ARM passive leg raising test (PLR-ΔMAP) for predicting ARM-induced hypotension (defined as MAP decrease ≥20% from baseline or MAP <65 mmHg during ARM).
AUC of PVI for Predicting ARM-Induced Hypotension
Time frame: Measured continuously from induction of general anesthesia until completion of the alveolar recruitment maneuver, assessed intraoperatively.
Area under the ROC curve (AUC) of pre-ARM pleth variability index (PVI) for predicting ARM-induced hypotension (defined as MAP decrease ≥20% from baseline or MAP <65 mmHg during ARM)
2 secondary outcomes
Correlation Between ARM-Induced ΔMAP% and Post-ARM Fluid Responsiveness
Time frame: From onset of ARM until 10 minutes after completion of ARM, assessed intraoperatively.
Comparative Diagnostic Accuracy of PLR Test versus PVI for Predicting ARM-Induced Hypotension
Time frame: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 37481588Desebbe O, Vallier S, Gergele L, Alexander B, Marx A, Ben Jaoude E, Kato H, Toubal L, Berna A, Duranteau J, Vincent JL, Joosten A. Diagnostic accuracy of the peripheral venous pressure variation induced by an alveolar recruitment maneuver to predict fluid responsiveness during high-risk abdominal surgery. BMC Anesthesiol. 2023 Jul 22;23(1):249. doi: 10.1186/s12871-023-02194-x.
- Background: PubMed 37480073Doughan A, Adingo W, Salifu SP. RNA-seq research landscape in Africa: systematic review reveals disparities and opportunities. Eur J Med Res. 2023 Jul 22;28(1):244. doi: 10.1186/s40001-023-01206-3.
- Background: PubMed 26682219Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Recruitment Maneuver (ARM) and Passive Leg Raising (PLR) Test in people with Hypotension Drug-Induced and General Anesthesia Using Endotracheal Intubation, run by University of Health Sciences Balikesir Hospital Eduation and Research 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?
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: opening soon, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasan Duman, M.D. (+905547317716, hasanduman.1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of ARM-Induced Hypotension by PLR Test and PVI (time frame: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.). The study lists 2 primary outcomes in all. 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 NCT07766967, which also lists 3 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 17 Aug 2026.