HiPEEP: Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP

Sponsor

Hospital Universitario La Fe (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06123039

Collaborator

(none)

Enrollment

Location

13.9

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational, prospective, single-centre study that will focus on patients undergoing major non-cardiac surgery requiring invasive mechanical ventilation and invasive blood pressure monitoring Hypotheses: A positive TVC (tidal volume challenge) prior to the recruitment manoeuvre (RM) predicts a decrease in CI within 5 minutes of individualised PEEP establishment of at least 10%.

T0: Moment prior to the start of tidal volume challenge. Baseline values
T1: After tidal volume challenge, moment priorate the start of the recruitment manoeuvre (RM). Mostcare and ventilator values.
T2: At minute 5 of establishing individualised PEEP. All parameters derived from basic monitoring, Mostcare, Masimo and ventilator monitoring shall be monitored and recorded. Record whether any fluid bolus has been administered.
T3: At minute 30 of establishing individualized PEEP. Blood gases and Masimo values.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Perioperative/Postoperative Complications Hypovolemia Haemodynamic Instability	Diagnostic Test: Tidal Volume Challenge Procedure: Recruitment maneuver obtaining individualised PEEP

Detailed Description

Lung recruitment manoeuvres (RM) are performed to prevent collapsed lung parenchyma from compromising oxygenation. In order to open collapsed lung areas, intrathoracic pressure needs to be raised and this may have haemodynamic repercussions especially in patients with an overt or latent hypovolaemic state. Parameters such as stroke volume variation (SVV) or pulse pressure variation (PPV) reflect to some extent the heart-lung interaction and have been used as predictors of fluid responsiveness by exploiting this principle to detect preload-dependent patients. The tidal volume challenge (TVC) uses the same principle of heart-lung interaction with better results. TVC can be a predictor of haemodynamic tolerance to RM + individualised PEEP.

Hypotheses: A positive TVC prior to the recruitment manoeuvre (RM) predicts a decrease in CI within 5 minutes of individualised PEEP establishment of at least 10%.

Data will be collected in the surgical area. Demographic and clinical parameters will be collected from the patient's clinical history, respiratory parameters obtained from the respirator, haemodynamic parameters obtained from the Mostcare and Masimo devices, oxygenation parameters and parameters obtained from blood gas analysis before and after a recruitment manoeuvre.

If the patient meets all inclusion criteria and none of the exclusion criteria, he/she will be included for data collection. If he/she benefits from a recruitment manoeuvre (air-test + clinical indication), which will be assessed by clinical indications, he/she will be entered into our study. All measurements will be taken under stable haemodynamic conditions (HR and MAP should be stable and with +-10% variation for 1 min prior to measurements), without administration of vasoactive drugs or influential surgical aggression at that time.

When the recruitment manoeuvre (RM) is performed, we will monitor all the variables by setting the following time points:

T0: Moment prior to the start of recruitment manoeuvre. All the variables described (Mostcare, blood gases, ventilator, Masimo, basic monitoring) and the administration of fluids prior to the manoeuvre shall be monitored. To avoid artefacts on the arterial waveform, a fast-flush test and assessment of dP/dtMAX should always be performed. Patients who do not have optimal arterial waveform morphology at this point will be excluded.
T1: At minute 1 after starting the VTC, the parameters derived from the basic monitoring and the Mostcare will be checked. From this moment on, the parameters obtained from Mostcare will be analysed continuously (minute by minute) until 15 minutes after establishing the individualised PEEP.
T2: At minute 5 of establishing individualised PEEP. All parameters derived from basic monitoring, Mostcare, Masimo and ventilator monitoring shall be monitored and recorded. Record whether any fluid bolus has been administered.
T3: Within 30 minutes of establishing individualised PEEP, venous and arterial blood gases shall be drawn. Record whether any fluid bolus has been administered.

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Use of Heart-lung Interaction Parameters to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP During Invasive Mechanical Ventilation in the Operating Room

Anticipated Study Start Date :

Nov 6, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
POSITIVE Tidal Volume Challenge Population with positive result in the tidal volume challenge. That is, an increase in PPV equal or greater than 3.5% or SVV equal or greater than 2.5% after increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute.	Diagnostic Test: Tidal Volume Challenge The tidal volume challenge is a fluid response test that consists of increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute and evaluating PPV and SVV. If these values increase the PPV by 3.5% or the SVV by 2.5%, it is considered positive, otherwise it will be negative. Procedure: Recruitment maneuver obtaining individualised PEEP The alveolar recruitment maneuver is a well-studied procedure to open the lung during invasive mechanical ventilation, allowing us to achieve the best PEEP for that lung, which is individualised PEEP.
NEGATIVE Tidal Volume Challenge Population with a negative result in the tidal volume challenge. That is, not enough increase in PPV or SVV.	Diagnostic Test: Tidal Volume Challenge The tidal volume challenge is a fluid response test that consists of increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute and evaluating PPV and SVV. If these values increase the PPV by 3.5% or the SVV by 2.5%, it is considered positive, otherwise it will be negative. Procedure: Recruitment maneuver obtaining individualised PEEP The alveolar recruitment maneuver is a well-studied procedure to open the lung during invasive mechanical ventilation, allowing us to achieve the best PEEP for that lung, which is individualised PEEP.

Arm

Intervention/Treatment

POSITIVE Tidal Volume Challenge

Population with positive result in the tidal volume challenge. That is, an increase in PPV equal or greater than 3.5% or SVV equal or greater than 2.5% after increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute.

Diagnostic Test: Tidal Volume Challenge

The tidal volume challenge is a fluid response test that consists of increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute and evaluating PPV and SVV. If these values increase the PPV by 3.5% or the SVV by 2.5%, it is considered positive, otherwise it will be negative.

Procedure: Recruitment maneuver obtaining individualised PEEP

The alveolar recruitment maneuver is a well-studied procedure to open the lung during invasive mechanical ventilation, allowing us to achieve the best PEEP for that lung, which is individualised PEEP.

NEGATIVE Tidal Volume Challenge

Population with a negative result in the tidal volume challenge. That is, not enough increase in PPV or SVV.

Diagnostic Test: Tidal Volume Challenge

Procedure: Recruitment maneuver obtaining individualised PEEP

Outcome Measures

Primary Outcome Measures

Tidal volume challenge as a predictor of haemodynamic tolerance to recruitment maneuver with individualized PEEP at minute 5 after recruitment maneuver [At minute 5 after recruitment maneuver]
To describe the relationship between baseline TVC and the difference in baseline and 5-minute CI (cardiac index) after RM with individualised PEEP. We consider a 10% decrease in CI as clinically significant.

Secondary Outcome Measures

Tidal volume challenge as a predictor of haemodynamic tolerance to recruitment maneuver with individualized PEEP at different moments in time [For 30 minutes from the recruitment maneuver]
o describe the relationship between baseline TVC and the difference in DO2 (cardiac index) at baseline and at 1 and 30 minutes after RM with individualised PEEP acquisition.
Stroke Volume Variation and Pulse Pressure Variation as predictors of haemodynamic tolerance to recruitment maneuver with individualized PEEP at different moments in time [For 30 minutes from the recruitment maneuver]
To describe the relationship between baseline PPV-SVV and the difference in CI (cardiac index) and DO2 at baseline and at 1, 5 and 30 minutes after RM with individualised PEEP acquisition.
Pressure Rating Analytical Method (PRAM) for monitoring haemodynamic effect of the Open Lung Approach with individualized PEEP [For 15 minutes from the recruitment maneuver]
To describe the effect of OLA (Open Lung Approach) with individualised PEEP on haemodynamic parameters obtained with minimally invasive monitoring using the PRAM method continuously during the first 15 minutes after RM with individualised PEEP compared to baseline values of: indexed systolic volume (ISV), cardiac index (CI), oxygen delivery (DO2), pulse pressure variation (PPV), dynamic arterial elastance (EaDyn), cardiovascular system impedance (z), dP/dtMAX and cardiac cycle efficiency (CCE).
Peripheral perfusion effect of individualized PEEP [At minute 30 after recruitment maneuver]
To study the outcome of individualised PEEP on peripheral perfusion (DO2, capillary refill time, arterial lactate and veno-arterial CO2 gap) at 30 minutes.
Compare invasive with non-invasive monitoring for pulse wave variation with respiratory cycle [Before recruitment maneuver]
To establish relationships between invasive and non-invasive parameters with similar physiological bases such as plethysmographic variation index (PVi/RPVi) and pulse wave variation with respiratory cycle (VVS, VPP)
Compare invasive with non-invasive monitoring for blood oxygenation [At minute 30 after recruitment maneuver]
To establish relationships between invasive and non-invasive parameters with similar physiological bases such as PaO2 and Ori

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients over 18 years of age; undergoing scheduled non-cardiothoracic surgery; under controlled invasive mechanical ventilation and invasive arterial monitoring; supine position.

Exclusion Criteria:

Chronic pulmonary disease (defined as chronic obstructive pulmonary disease grade 3 or higher or any disease requiring long-term oxygen therapy); congenital cardiac malformations; severe valvular heart disease; heart failure NYHA (New York Heart Association) Grade III/IV; arrhythmias; history of reduced ventricular systolic function (FEVI <40% or TAPSE <17 cm/s); history of pulmonary hypertension; BMI >35 (due to altered lung compliance and rib cage); heart rate/respiratory rate ratio < 3.6; presence of inspiratory effort; open chest; increased intra-abdominal pressure (due to pathology or pneumoperitoneum); altered pulmonary or rib cage compliance due to surgery (trendelemburg or antitrendelemburg position); uncorrected optimal arterial waveform (resonant or damped) and presence of any contraindication to lung recruitment manoeuvres. The latter are: pulmonary emphysema, pulmonary bullae, uncontrolled haemodynamic instability, right heart failure, elevated intracranial pressure (decreased return flow through jugular veins) or lack of monitoring if necessary, bronchospasm, undrained pneumothorax.