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Completed

NCT Number: NCT06123039

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

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%.

1. T0: Moment prior to the start of tidal volume challenge. Baseline values 2. T1: After tidal volume challenge, moment priorate the start of the recruitment manoeuvre (RM). Mostcare and ventilator values. From this moment on, the parameters obtained from Mostcare will be analysed continuously (minute by minute) until 15 minutes after establishing the individualised PEEP. 3. T2: At minute 5 of establishing individualised PEEP. All parameters derived from basic monitoring, Mostcare, and ventilator monitoring shall be monitored and recorded. Record whether any fluid bolus has been administered.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario La Fe

Valencia, Spain

About this study

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

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 device, oxygenation parameters 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, ventilator, 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 and ventilator monitoring shall be monitored and recorded. Record whether any fluid bolus has been administered.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Tidal volume challenge

Diagnostic Test

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. If PPV increases by more than 2%, it is considered positive, otherwise it will be negative.

Recruitment maneuver obtaining individualised PEEP

Procedure

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.

Primary outcomes

  1. Tidal volume challenge as a predictor of hemodynamic response to Open Lung Approach

    Time frame: At minute 5 after recruitment maneuver

    To describe the relationship between baseline Tidal Volume Challenge and the difference in baseline and 5-minute CI (cardiac index) after Recruitment Maneuver with individualised PEEP (Open Lung Approach). We consider a 10% decrease in CI as clinically significant.

Secondary outcomes

  1. Heart-lung interactions to predict hemodynamic response to Open Lung Approach

    Time frame: 5 minutes after RM

    To describe the relationship between baseline Heart-lung interactions (Changes in Pulse pressure variation with Tidal Volume Challenge, Pulse pressure variation at 6 or 8 ml/kg of tidal volume and Stroke Volume variation at 6 or 8 ml/kg of tidal volume) and the difference in Cardiac Index at baseline and at 1 and 5 minute after Recruitment Maneuver with individualised PEEP acquisition (Open Lung Approach).

  2. Heart lung interactions as predictors of hemodynamic tolerance to Open Lung Apprach assessed by Mean Arterial Pressure

    Time frame: For 5 minutes from the recruitment maneuver

    To describe the relationship between baseline Heart-lung interactions (Changes in Pulse pressure variation with Tidal Volume Challenge, Tidal Volume Challenge, Pulse pressure variation at 6 or 8 ml/kg of tidal volume and Stroke Volume variation at 6 or 8 ml/kg of tidal volume) and the difference in Mean Arterial Pressure at baseline and at 1 and 5 minutes after Recruitment Maneuver with individualised PEEP acquisition (Open Lung Approach).

  3. CI and MAP correlation for assessing hemodynamic impact of Open Lung Approach

    Time frame: For 5 minutes from the recruitment maneuver

    To assess whether changes in CI are correlated with changes in Mean Arterial Pressure (MAP) before and after the RM with individualised PEEP (Open Lung Approach).

  4. Heart-lung interactions as predictors of hemodynamic tolerance to Open Lung Approach over time

    Time frame: For 15 minutes from the recruitment maneuver

    To describe the relationship between baseline heart lung interactions (TVC and Pulse pressure Variation) and the difference in CI (cardiac index), stroke volume variation and Mean arterial Pressure at baseline and the 15 minutes following RM with individualised PEEP acquisition (Open Lung Approach).

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study 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

Acronym: HiPEEP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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