An observational study in Anesthesia, Perioperative/Postoperative Complications and Hypovolemia, sponsored by Hospital Universitario La Fe. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Hospital Universitario La Fe · Observational
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%.
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:
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 72 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Hospital Universitario La Fe is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: At minute 5 after recruitment maneuver
Heart-lung interactions to predict hemodynamic response to Open Lung Approach
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).
Time frame: 5 minutes after RM
Heart lung interactions as predictors of hemodynamic tolerance to Open Lung Apprach assessed by Mean Arterial Pressure
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).
Time frame: For 5 minutes from the recruitment maneuver
CI and MAP correlation for assessing hemodynamic impact of Open Lung Approach
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).
Time frame: For 5 minutes from the recruitment maneuver
Heart-lung interactions as predictors of hemodynamic tolerance to Open Lung Approach over time
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).
Time frame: For 15 minutes from the recruitment maneuver
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Hospital Universitario La Fe