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Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness

Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Outcome and Intraoperative Indicator of Fluid Responsiveness

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07766967
Enrollment
70
Registered
2026-08-17
Start date
2026-07-15
Completion date
2026-09-29
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atelectasis, Fluid Responsiveness, General Anesthesia Using Endotracheal Intubation, Hypotension Drug-Induced, Mechanical Ventilation

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

Brief 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). 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.

Interventions

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.

Sponsors

University of Health Sciences Balikesir Hospital Eduation and Research
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Prediction of ARM-Induced Hypotension by PLR Test and PVIFrom 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 HypotensionMeasured 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)

Secondary

MeasureTime frameDescription
Correlation Between ARM-Induced ΔMAP% and Post-ARM Fluid ResponsivenessFrom onset of ARM until 10 minutes after completion of ARM, assessed intraoperatively.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.
Comparative Diagnostic Accuracy of PLR Test versus PVI for Predicting ARM-Induced HypotensionFrom induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.The difference in AUC values between PLR-ΔMAP and PVI will be compared using the DeLong method.

Countries

Turkey (Türkiye)

Contacts

CONTACTHasan Duman, M.D.
hasanduman.1991@gmail.com+905547317716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026