Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation

NCT04924920 | Recruiting

• 1 other identifier: SIGH_EEOT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The application of a brief SIGH of 4 seconds at 35 cmH20 has shown to reliably predict fluid responsiveness in critically ill patients undergoing pressure support ventilation. The end-expiratory occlusion test (EEOT) has been also used in the same type of patients, with the same purpose, but in a limited amount of studies. The aim of this study is to compare the reliability of the the two test in assessing fluid responsiveness.

Conditions

Critically Ill Patients; Hemodynamic Instability; Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (2)

• Pulse pressure prediction of fluid responsiveness

  Pulse pressure changes after SIGH35 application

  Evaluated before and after SIGH35 (within 1 minute from SIGH35 application)

• Stroke volume prediction of fluid responsiveness

  Stroke Volume changes after SIGH35 application

  Evaluated before and after SIGH35 (within 1 minute from SIGH35 application)

Secondary Outcomes (2)

• Pulse pressure prediction of fluid responsiveness

  Evaluated before and after EEOT (within 1 minute from EEOT application)

• Stroke volume prediction of fluid responsiveness

  Evaluated before and after EEOT (within 1 minute from EEOT application)

Other Outcomes (2)

• Rate of failure of SIGH test

  During the test execution

• Rate of failure of EEOT test

  During the test execution

Study Arms (1)

Intervention EEO_SIGH

EXPERIMENTAL

Single arm intervention. All the patients will receive the two tests (SIGH and EEOT) in 1:1 random sequence order

Diagnostic Test: SIGH; Diagnostic Test: EEOT; Diagnostic Test: Fluid challenge

Interventions

SIGH DIAGNOSTIC_TEST

To add the Sigh35 to PSV, the ventilator is set in pressure controlled synchronized intermittent mandatory ventilation plus PSV \[SIMV (PC) + PS mode\], with SIMV rate set a 1/min and inspiratory time of 4 seconds. SIMV (PC) = 35 cmH20 of total inspiratory support (PEEP + PS).

Intervention EEO_SIGH

EEOT DIAGNOSTIC_TEST

• The EEOT is performed by interrupting the mechanical ventilation for 15 seconds, by using and end-expiratory hold on the ventilator. The ventilator trigger is set at 2 L/min.

Intervention EEO_SIGH

Fluid challenge DIAGNOSTIC_TEST

Bolus of fluids of 4 ml/kg given within 10 minutes

Intervention EEO_SIGH

Eligibility Criteria

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

You may not qualify if:

• left ventricular ejection fraction \<30% or severe valvular dysfunction
• atrial fibrillation
• severe acute respiratory distress syndrome (ARDS)
• abdominal compartment syndrome
• air leakage through chest drains
• artifacts in arterial waveform
• pathological respiratory patterns due to neurological diseases
• signs of fatigue or respiratory distress

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (2)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, Milano, Italy

RECRUITING

Related Publications (3)

• Messina A, Colombo D, Barra FL, Cammarota G, De Mattei G, Longhini F, Romagnoli S, DellaCorte F, De Backer D, Cecconi M, Navalesi P. Sigh maneuver to enhance assessment of fluid responsiveness during pressure support ventilation. Crit Care. 2019 Jan 28;23(1):31. doi: 10.1186/s13054-018-2294-4.

  PMID: 30691523 BACKGROUND

• Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94. doi: 10.1097/00000542-200204000-00004.

  PMID: 11964584 BACKGROUND

• Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.

  PMID: 19237902 BACKGROUND

Study Design

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

Model Details: Cross-over design. The study has one single arm cross-over treatment design. The same patient will be assessed by means of the two tests. The sequence of application will be randomly generated and applied to the patients.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 14, 2021
• Study Start: February 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IT (2)