End-expiratory Occlusion Test and Lung Recruitment Maneuver to Assess Fluid responsiVeness In Surgical Patients

NCT03820440 | Unknown

• 1 other identifier: ELVIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The functional hemodynamic test (FHT) called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR. A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle SV. A second subgroup aims at testing the increase in SV after the rapid administration of a small aliquot of the predefined FC. Among the first group, the end-expiratory occlusion test (EEOT) and the lung recruitment maneuver (LRM) have been previously successfully tested in surgical patients. The EEOT consists of the interruption of the mechanical ventilation for 30 seconds, whereas the LRM consists in the increase in the peak inspiratory pressure up to 30 cmH20 for 30 seconds and in the assessment of the changes in the SV after the maneuvers. These tests are safe and can be easily applicable during the surgery to predict fluid responsiveness and optimize the fluid therapy. The primary aim of the present study is to compare the reliability of EEOT and LRM in predicting fluid responsiveness in patients undergoing general surgery.

Conditions

Hemodynamic Instability; Surgery; Fluid Overload

Keywords

End-expiratory occlusion test; Lung Recruitment Manovre; Fluid responsiveness; Functional Hemodynamic Test

Outcome Measures

Primary Outcomes (1)

• AUC difference

  To assess the difference in the area under (AUC) the receiving operator characteristic curve (ROC)

  10 minutes after fluid challenge administration

Secondary Outcomes (1)

• Sensitivity and Specificity

  10 minutes after fluid challenge administration

Study Arms (1)

Treatment - hemodynamic tests

EXPERIMENTAL

Treatment - hemodynamic tests: The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator. The LRM is performed by using a single act of mechanical ventilation in pressure-controlled mode at 30 cmH20 for 30 seconds

Diagnostic Test: End-expiratory occlusion test (EEOT); Diagnostic Test: Lung recruitment manovre (LRM)

Interventions

End-expiratory occlusion test (EEOT) DIAGNOSTIC_TEST

The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator.

Treatment - hemodynamic tests

Lung recruitment manovre (LRM) DIAGNOSTIC_TEST

The LRM is performed by using a single act of mechanical ventilation in pressure-controlled mode at 30 cmH20 for 30 seconds

Treatment - hemodynamic tests

Eligibility Criteria

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

You may qualify if:

• Adult patients aged ≥ 18 years;
• Scheduled for elective supine abdominal surgery and requiring invasive arterial monitoring;
• Glasgow coma scale 15 at recruitment. All the patients must be able to sign an informed consent at the admission.

You may not qualify if:

• Any recurrent cardiac arrhythmias;
• Reduced left (ejection fraction \<30%) or right (systolic peak velocity of tricuspid annular motion \<0.17 m/s) ventricular systolic function;
• Chronic use beta-blocking agents.
• History of pneumothorax.
• BMI \> 40

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Publications (2)

• Biais M, Larghi M, Henriot J, de Courson H, Sesay M, Nouette-Gaulain K. End-Expiratory Occlusion Test Predicts Fluid Responsiveness in Patients With Protective Ventilation in the Operating Room. Anesth Analg. 2017 Dec;125(6):1889-1895. doi: 10.1213/ANE.0000000000002322.

  PMID: 28742783 RESULT

• Biais M, Lanchon R, Sesay M, Le Gall L, Pereira B, Futier E, Nouette-Gaulain K. Changes in Stroke Volume Induced by Lung Recruitment Maneuver Predict Fluid Responsiveness in Mechanically Ventilated Patients in the Operating Room. Anesthesiology. 2017 Feb;126(2):260-267. doi: 10.1097/ALN.0000000000001459.

  PMID: 27922547 RESULT

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU senior consultant

Model Details: The study protocol is started during a period of intraoperative hemodynamic stability, as previously defined (change in mean arterial pressure of less than 10% during 5 minutes). The study protocol is the following: 1) a set of measurements is recorded (T0) at a baseline ventilation of 7 ml/Kg and then the EEOT is performed by using the software function, "expiratory hold", to interrupt mechanical ventilation; 2) after one minute a set of measurements was recorded (T1); 3) the LRM is then performed; 4) after one minute another set of measurements is recorded (T2) and then a fluid challenge of 4 mL/Kg of crystalloid solution is infused over 10 minutes. The attending anesthetist is allowed to interrupt the protocol at any stage for either hemodynamic instability or any other adverse effects requiring urgent treatment. The sequence of application of EEOT and LRM on the same patient (EEOT\_LRM or LRM\_EEOT) is randomly generated.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: May 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

IT (1)