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

NCT07766967 | Not Yet Recruiting

• 1 other identifier: hasanduman3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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; Lung-protective ventilation; Perioperative hemodynamics

Outcome Measures

Primary Outcomes (2)

• 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).

  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 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

  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

  From induction of general anesthesia until 5 minutes after completion of the alveolar recruitment maneuver, assessed intraoperatively.

Study Arms (1)

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.

Device: Alveolar Recruitment Maneuver (ARM); Behavioral: Passive Leg Raising (PLR) Test

Interventions

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.

ARM-Induced Hypotension Prediction Group

Passive Leg Raising (PLR) Test BEHAVIORAL

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.

ARM-Induced Hypotension Prediction Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Health Sciences Balikesir Hospital Eduation and Research: lead

Study Sites (1)

Balıkesir Atatürk City Hospital

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 37481588 BACKGROUND

• Doughan 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.

  PMID: 37480073 BACKGROUND

• Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.

  PMID: 26682219 BACKGROUND

MeSH Terms

Conditions

Hypotension; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hasan Duman, M.D.

CONTACT

+905547317716; hasanduman.1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 17, 2026
• Study Start: July 15, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 29, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)