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

February 13, 2024 updated by: Oscar Diaz-Cambronero, Hospital Universitario La Fe

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  1. 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.
  2. 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.
  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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
          • Guido Mazzinari, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing scheduled non-cardiothoracic surgery under controlled invasive mechanical ventilation and invasive arterial monitoring, without pathologies that affect heart-lung interactions and their interpretation. They would be patients who benefit from a recruitment maneuver.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POSITIVE Tidal Volume Challenge
Population with positive result in the tidal volume challenge. That is, an increase in PPV greater than 2% after increasing the tidal volume from 6 ml/kg to 8 ml/kg for 1 minute.
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.
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. If PPV increases by more than 2%, it is considered positive, otherwise it will be negative.
NEGATIVE Tidal Volume Challenge
Population with a negative result in the tidal volume challenge. That is, not enough increase in PPV.
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.
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. If PPV increases by more than 2%, it is considered positive, otherwise it will be negative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal volume challenge as a predictor of haemodynamic tolerance to recruitment maneuver with individualized PEEP at minute 5 after recruitment maneuver
Time Frame: 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.
At minute 5 after recruitment maneuver

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Rating Analytical Method (PRAM) for monitoring haemodynamic effect of the Open Lung Approach with individualized PEEP
Time Frame: 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).
For 15 minutes from the recruitment maneuver
Tidal volume challenge as a predictor of haemodynamic tolerance to recruitment maneuver with individualized PEEP at different moments in time
Time Frame: For 15 minutes from the recruitment maneuver
To 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.
For 15 minutes from the recruitment maneuver
Stroke Volume Variation and Pulse Pressure Variation as predictors of haemodynamic tolerance to recruitment maneuver with individualized PEEP at different moments in time
Time Frame: For 15 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.
For 15 minutes from the recruitment maneuver

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Investigators

  • Principal Investigator: Jose Daniel Jimenez Santana, Resident, University and Polytechnic Hospital La fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiPEEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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