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

NCT06123039 | Completed

• 1 other identifier: HiPEEP
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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%.

1. 1.T0: Moment prior to the start of tidal volume challenge. Baseline values
2. 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. 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.

Conditions

Anesthesia; Perioperative/Postoperative Complications; Hypovolemia; Haemodynamic Instability

Keywords

Tidal Volume Challenge; Recruitment Maneuver; Haemodynamic monitoring; Heart-lung interactions; Stroke Volume Variation; Pulse Pressure Variation; Cardiac Index; PEEP

Outcome Measures

Primary Outcomes (1)

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

  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.

  At minute 5 after recruitment maneuver

Secondary Outcomes (4)

• Heart-lung interactions to predict hemodynamic response to Open Lung Approach

  5 minutes after RM

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

  For 5 minutes from the recruitment maneuver

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

  For 5 minutes from the recruitment maneuver

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

  For 15 minutes from the recruitment maneuver

Study Arms (2)

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.

Diagnostic Test: Tidal Volume Challenge; Procedure: Recruitment maneuver obtaining individualised PEEP

NEGATIVE Tidal Volume Challenge

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

Diagnostic Test: Tidal Volume Challenge; Procedure: Recruitment maneuver obtaining individualised PEEP

Interventions

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.

NEGATIVE Tidal Volume Challenge; POSITIVE Tidal Volume Challenge

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.

NEGATIVE Tidal Volume Challenge; POSITIVE Tidal Volume Challenge

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario La Fe

Valencia, Spain

Location

Related Publications (58)

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  BACKGROUND

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MeSH Terms

Conditions

Postoperative Complications; Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Daniel Jimenez Santana, Resident

  University and Polytechnic Hospital La fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of the perioperative medicine group

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 8, 2023
• Study Start: November 6, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

ES (1)