Tidal Volume Challenge to Assess Volume Responsiveness

NCT05254951 | Completed

• 1 other identifier: TVchallenge
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the ability of changes in PPV and SVV after Tidal Volume Challenge to predict fluid responsiveness in patients undergoing general anesthesia with protective mechanical ventilation.

Conditions

Fluid Overload; Mechanical Ventilation

Keywords

Protective Mechanical Ventilation; Fluid responsiveness; Tidal Volume Challenge; Preload index; Pulse pressure variation; Stroke volume variation

Outcome Measures

Primary Outcomes (2)

• Delta(Δ) PPV(T2-T1)

  the difference between PPVT2 and PPVT1

  intraoperative, one hour and 3 minutes after anesthesia induction

• Delta (Δ)SVV(T2-T1)

  the difference between SVVT2 and SVVT1

  intraoperative, one hour and 3 minutes after anesthesia induction

Secondary Outcomes (14)

• PPVT1

  intraoperative, one hour after anesthesia induction

• PPVT2

  intraoperative, one hour and 3 minutes after anesthesia induction

• SVVT1

  intraoperative, one hour after anesthesia induction

• SVVT2

  intraoperative, one hour and 3 minutes after anesthesia induction

• PPVT3

  intraoperative, one hour and 8 minutes after anesthesia induction

Study Arms (1)

Patients enrolled in the protocol

EXPERIMENTAL

Patients will receive a tidal volume challenge to assess fluid responsiveness and then a volume expansion bolus to classify them into responders and not responders

Diagnostic Test: Tidal Volume Challenge

Interventions

Tidal Volume Challenge DIAGNOSTIC_TEST

Tidal Volume Challenge to predict fluid responsiveness with stroke volume variation and pulse pressure variation

Patients enrolled in the protocol

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age
• General surgery or Vascular surgery patients without clamping of the aorta.
• Will require arterial cannulation and invasive blood pressure monitoring during surgery
• The expected duration of the operation will be equal to or greater than 90 minutes

You may not qualify if:

• preoperative arrhythmia or newly emergent arrhythmia after anesthesia induction
• Reduced left (EF \< 40%) or right systolic function
• BMI \>30
• Preoperative use of beta-blockers
• Chronic obstructive pulmonary disease with FEV1 \<60% predicted volume

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University Hospital

Athens, Attica, 12461, Greece

Location

Related Publications (11)

• Thacker JK, Mountford WK, Ernst FR, Krukas MR, Mythen MM. Perioperative Fluid Utilization Variability and Association With Outcomes: Considerations for Enhanced Recovery Efforts in Sample US Surgical Populations. Ann Surg. 2016 Mar;263(3):502-10. doi: 10.1097/SLA.0000000000001402.

  PMID: 26565138 BACKGROUND

• Navarro LH, Bloomstone JA, Auler JO Jr, Cannesson M, Rocca GD, Gan TJ, Kinsky M, Magder S, Miller TE, Mythen M, Perel A, Reuter DA, Pinsky MR, Kramer GC. Perioperative fluid therapy: a statement from the international Fluid Optimization Group. Perioper Med (Lond). 2015 Apr 10;4:3. doi: 10.1186/s13741-015-0014-z. eCollection 2015.

  PMID: 25897397 BACKGROUND

• Loftus TJ, Stelton S, Efaw BW, Bloomstone J. A System-Wide Enhanced Recovery Program Focusing on Two Key Process Steps Reduces Complications and Readmissions in Patients Undergoing Bowel Surgery. J Healthc Qual. 2017 May/Jun;39(3):129-135. doi: 10.1111/jhq.12068.

  PMID: 28481841 BACKGROUND

• Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.

  PMID: 21508838 BACKGROUND

• Pinsky MR. Heart lung interactions during mechanical ventilation. Curr Opin Crit Care. 2012 Jun;18(3):256-60. doi: 10.1097/MCC.0b013e3283532b73.

  PMID: 22473256 BACKGROUND

• Biais M, Ehrmann S, Mari A, Conte B, Mahjoub Y, Desebbe O, Pottecher J, Lakhal K, Benzekri-Lefevre D, Molinari N, Boulain T, Lefrant JY, Muller L; AzuRea Group. Clinical relevance of pulse pressure variations for predicting fluid responsiveness in mechanically ventilated intensive care unit patients: the grey zone approach. Crit Care. 2014 Nov 4;18(6):587. doi: 10.1186/s13054-014-0587-9.

  PMID: 25658489 BACKGROUND

• Mahjoub Y, Lejeune V, Muller L, Perbet S, Zieleskiewicz L, Bart F, Veber B, Paugam-Burtz C, Jaber S, Ayham A, Zogheib E, Lasocki S, Vieillard-Baron A, Quintard H, Joannes-Boyau O, Plantefeve G, Montravers P, Duperret S, Lakhdari M, Ammenouche N, Lorne E, Slama M, Dupont H. Evaluation of pulse pressure variation validity criteria in critically ill patients: a prospective observational multicentre point-prevalence study. Br J Anaesth. 2014 Apr;112(4):681-5. doi: 10.1093/bja/aet442. Epub 2013 Dec 29.

  PMID: 24374504 BACKGROUND

• De Backer D, Heenen S, Piagnerelli M, Koch M, Vincent JL. Pulse pressure variations to predict fluid responsiveness: influence of tidal volume. Intensive Care Med. 2005 Apr;31(4):517-23. doi: 10.1007/s00134-005-2586-4. Epub 2005 Mar 8.

  PMID: 15754196 BACKGROUND

• 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.

  PMID: 27922879 BACKGROUND

• Messina A, Montagnini C, Cammarota G, Giuliani F, Muratore L, Baggiani M, Bennett V, Della Corte F, Navalesi P, Cecconi M. Assessment of Fluid Responsiveness in Prone Neurosurgical Patients Undergoing Protective Ventilation: Role of Dynamic Indices, Tidal Volume Challenge, and End-Expiratory Occlusion Test. Anesth Analg. 2020 Mar;130(3):752-761. doi: 10.1213/ANE.0000000000004494.

  PMID: 31651455 BACKGROUND

• Messina A, Montagnini C, Cammarota G, De Rosa S, Giuliani F, Muratore L, Della Corte F, Navalesi P, Cecconi M. Tidal volume challenge to predict fluid responsiveness in the operating room: An observational study. Eur J Anaesthesiol. 2019 Aug;36(8):583-591. doi: 10.1097/EJA.0000000000000998.

  PMID: 31021879 BACKGROUND

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: Associate Professor of Anesthesiology

Model Details: Interventional Prospective Study

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: February 24, 2022
• Study Start: March 30, 2022
• Primary Completion: September 19, 2023
• Study Completion: November 1, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the completion of the study for 5 years

Locations

GR (1)