Assessment of Preload Responsiveness in ARDS Patients During Prone Position

NCT04457739 | Completed

• 1 other identifier: 2019-A00064-53
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of preload responsiveness in ARDS patients during prone position is difficult and only one study showed Trendelenburg manoeuvre can be used in this group of patients. This study aims to investigate whether end-expiratory occlusion test, tidal volume challenge (using the changes in PPV) can be used to evaluate preload responsiveness in patients with ARDS ventilated with a low tidal volume and who underwent a PP session.

Conditions

Acute Respiratory Distress Syndrome; Septic Shock; Hemodynamic Instability

Keywords

Hemodynamic monitoring; preload responsiveness; ARDS; Fluid therapy

Outcome Measures

Primary Outcomes (1)

• Area under ROC curve of the change in pulse pressure variation during tidal volume challenge to detect preload responsiveness

  1 minute after increasing tidal volume from 6 to 8mL/kg

Secondary Outcomes (1)

• Area under ROC curve of the pulse pressure variation in tidal volume of 8ml/kg in continuous cardiac output during end-expiratory occlusion to detect preload dependence

  1 minute after tidal volume increase to 8 ml/kg

Interventions

Tidal volume challenge OTHER

Increasing tidal volume from 6 to 8 mL/kg during 1 min

End-expiratory occlusion test OTHER

Interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output

Trendelenburg maneuver OTHER

Patients remained in prone position with a 13° upward bed angulation throughout the study and then be positioned in a declining position at -12 ° for 1 minute

Eligibility Criteria

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

Study Population

Patients with severe ARDS (according to the Berlin definition) undergoing a prone position session, already monitored with a transpulmonary thermodilution device and for whom the evaluation of preload responsiveness is needed owing to the occurrence of hemodynamic instability.

You may qualify if:

• ARDS patient
• Prone position
• Monitored by transpulmonary thermodilution and pulse contour analysis

You may not qualify if:

• Age below 18
• No social security
• Refuse to participate in the study

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

Location

Related Publications (18)

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• Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

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• Shi R, Ayed S, Moretto F, Azzolina D, De Vita N, Gavelli F, Carelli S, Pavot A, Lai C, Monnet X, Teboul JL. Tidal volume challenge to predict preload responsiveness in patients with acute respiratory distress syndrome under prone position. Crit Care. 2022 Jul 18;26(1):219. doi: 10.1186/s13054-022-04087-w.

  PMID: 35850771 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Shock, Septic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: January 8, 2019
• Primary Completion: May 6, 2021
• Study Completion: December 31, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

FR (1)