An interventional study of Alveolar Recruitment Maneuver (ARM) and Passive Leg Raising (PLR) Test in Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation and Atelectasis, sponsored by University of Health Sciences Balikesir Hospital Eduation and Research. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of Health Sciences Balikesir Hospital Eduation and Research · Not applicable, Interventional, and Diagnostic
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 70 is below the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →University of Health Sciences Balikesir Hospital Eduation and Research is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:Age 18 years or older I or II Scheduled for elective non-cardiac, non-thoracic surgery under general anesthesia Able to provide written -
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%) (COPD) or severe respiratory disease Atrial fibrillation or other significant arrhythmias Peripheral vascular disease affecting PVI signal quality (BMI) >40 kg/m² Emergency surgery Refusal to participate or inability to provide informed consent Pregnancy
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Alveolar Recruitment Maneuver (ARM) · Behavioral: Passive Leg Raising (PLR) Test
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.
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.
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).
Time frame: 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)
Time frame: Measured continuously from induction of general anesthesia until completion of the alveolar recruitment maneuver, assessed intraoperatively.
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.
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
The difference in AUC values between PLR-ΔMAP and PVI will be compared using the DeLong method.
Time frame: From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Sep 2026, 2 months later.
Of 210 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's planned 2 months is below that.
Counting every sponsor, half of 217 studies reached it within 12 months; a quarter within 6 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Balikesir Hospital Eduation and Research