AnesthesiaHiPEEPNCT06123039
Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
An observational study of Anesthesia and Perioperative/Postoperative Complications, run by Hospital Universitario La Fe at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Perioperative/Postoperative Complications, Hypovolemia
- What is being tested?
- Tidal Volume Challenge and Recruitment maneuver obtaining individualised PEEP
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 6 Nov 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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. 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.
Read the 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:
- 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.
- Conditions
- Anesthesia, Perioperative/Postoperative Complications, Hypovolemia, Haemodynamic Instability
- Being tested
- Tidal Volume Challenge, Recruitment maneuver obtaining individualised PEEP
- Keywords
- Tidal Volume Challenge, Recruitment Maneuver, Haemodynamic monitoring, Heart-lung interactions, Stroke Volume Variation, Pulse Pressure Variation, Cardiac Index, PEEP
- Medical subject headings
- Postoperative Complications, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Volume ChallengeDiagnostic 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 PEEPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Tidal Volume Challenge; Procedure: Recruitment maneuver obtaining individualised PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At minute 5 after recruitment maneuver
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: For 15 minutes from the recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start6 Nov 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
- Investigators
- Jose Daniel Jimenez Santana, Resident, Principal investigator, University and Polytechnic Hospital La fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123039
- Sponsor's protocol ID
- HiPEEP
- Acronym
- HiPEEP
- Status last verified
- Mar 2025
- First submitted
- 5 Nov 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia-Fernandez J, Romero A, Blanco A, Gonzalez P, Abad-Gurumeta A, Bergese SD. Recruitment manoeuvres in anaesthesia: How many more excuses are there not to use them? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):209-217. doi: 10.1016/j.redar.2017.12.006. Epub 2018 Feb 10. English, Spanish.
PubMed 293951102. García - Fernández J, Mingote A, Marrero R. VENTIMEC. Tratado de Ventilación Mecánica en Anestesiología, Cuidados Intensivos y Trasplantes. Panamericana 2022.
Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.
PubMed 25435480Pinsky MR. Cardiopulmonary Interactions: Physiologic Basis and Clinical Applications. Ann Am Thorac Soc. 2018 Feb;15(Suppl 1):S45-S48. doi: 10.1513/AnnalsATS.201704-339FR.
PubMed 28820609Vargas M, Sutherasan Y, Gregoretti C, Pelosi P. PEEP role in ICU and operating room: from pathophysiology to clinical practice. ScientificWorldJournal. 2014 Jan 14;2014:852356. doi: 10.1155/2014/852356. eCollection 2014.
PubMed 24719580Jardin F, Vieillard-Baron A. Right ventricular function and positive pressure ventilation in clinical practice: from hemodynamic subsets to respirator settings. Intensive Care Med. 2003 Sep;29(9):1426-34. doi: 10.1007/s00134-003-1873-1. Epub 2003 Aug 9. No abstract available.
PubMed 12910335Alexi-Meskhisvili VV, Falkowski GE, Nikoljuk AP, Popov SA. Hemodynamic changes during mechanical ventilation in infants and small children after open heart surgery. Thorac Cardiovasc Surg. 1985 Aug;33(4):215-7. doi: 10.1055/s-2007-1014122.
PubMed 2413570Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19.
PubMed 33991896Stohl S, Klein MJ, Ross PA, vonBusse S, Menteer J. Impact of Anesthetic and Ventilation Strategies on Invasive Hemodynamic Measurements in Pediatric Heart Transplant Recipients. Pediatr Cardiol. 2020 Jun;41(5):962-971. doi: 10.1007/s00246-020-02344-9. Epub 2020 Jun 18.
PubMed 32556487Eerdekens R, Bouwmeester S. Atrial septal defect and haemodynamic consequences of continuous positive airway pressure treatment. Lancet. 2020 Jun 13;395(10240):1864. doi: 10.1016/S0140-6736(20)31251-4. No abstract available.
PubMed 32534648Horn AG, Baumfalk DR, Schulze KM, Kunkel ON, Colburn TD, Weber RE, Bruells CS, Musch TI, Poole DC, Behnke BJ. Effects of elevated positive end-expiratory pressure on diaphragmatic blood flow and vascular resistance during mechanical ventilation. J Appl Physiol (1985). 2020 Sep 1;129(3):626-635. doi: 10.1152/japplphysiol.00320.2020. Epub 2020 Jul 30.
PubMed 32730173Michard F, Chemla D, Richard C, Wysocki M, Pinsky MR, Lecarpentier Y, Teboul JL. Clinical use of respiratory changes in arterial pulse pressure to monitor the hemodynamic effects of PEEP. Am J Respir Crit Care Med. 1999 Mar;159(3):935-9. doi: 10.1164/ajrccm.159.3.9805077.
PubMed 10051276Luecke T, Pelosi P. Clinical review: Positive end-expiratory pressure and cardiac output. Crit Care. 2005;9(6):607-21. doi: 10.1186/cc3877. Epub 2005 Oct 18.
PubMed 16356246Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
PubMed 26682219Herbst-Rodrigues MV, Carvalho VO, Auler JO Jr, Feltrim MI. PEEP-ZEEP technique: cardiorespiratory repercussions in mechanically ventilated patients submitted to a coronary artery bypass graft surgery. J Cardiothorac Surg. 2011 Sep 13;6:108. doi: 10.1186/1749-8090-6-108.
PubMed 21914178
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06123039
- Acronym / sponsor ID
- HiPEEP / HiPEEP
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POSITIVE Tidal Volume Challenge | – | Diagnostic Test: Tidal Volume Challenge, Procedure: Recruitment maneuver obtaining individualised PEEPPopulation 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. |
| NEGATIVE Tidal Volume Challenge | – | Diagnostic Test: Tidal Volume Challenge, Procedure: Recruitment maneuver obtaining individualised PEEPPopulation with a negative result in the tidal volume challenge. That is, not enough increase in PPV. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tidal Volume ChallengeThe 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. | Diagnostic test | NEGATIVE Tidal Volume Challenge, POSITIVE Tidal Volume Challenge |
| Recruitment maneuver obtaining individualised PEEPThe 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. | Procedure or surgery | NEGATIVE Tidal Volume Challenge, POSITIVE Tidal Volume Challenge |
Primary outcome
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.
4 secondary outcomes
Heart-lung interactions to predict hemodynamic response to 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
Time frame: For 5 minutes from the recruitment maneuver
CI and MAP correlation for assessing hemodynamic impact of 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
Time frame: For 15 minutes from the recruitment maneuver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 29395110Garcia-Fernandez J, Romero A, Blanco A, Gonzalez P, Abad-Gurumeta A, Bergese SD. Recruitment manoeuvres in anaesthesia: How many more excuses are there not to use them? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):209-217. doi: 10.1016/j.redar.2017.12.006. Epub 2018 Feb 10. English, Spanish.
- Background2. García - Fernández J, Mingote A, Marrero R. VENTIMEC. Tratado de Ventilación Mecánica en Anestesiología, Cuidados Intensivos y Trasplantes. Panamericana 2022.
- Background: PubMed 25435480Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.
- Background: PubMed 28820609Pinsky MR. Cardiopulmonary Interactions: Physiologic Basis and Clinical Applications. Ann Am Thorac Soc. 2018 Feb;15(Suppl 1):S45-S48. doi: 10.1513/AnnalsATS.201704-339FR.
- Background: PubMed 24719580Vargas M, Sutherasan Y, Gregoretti C, Pelosi P. PEEP role in ICU and operating room: from pathophysiology to clinical practice. ScientificWorldJournal. 2014 Jan 14;2014:852356. doi: 10.1155/2014/852356. eCollection 2014.
- Background: PubMed 12910335Jardin F, Vieillard-Baron A. Right ventricular function and positive pressure ventilation in clinical practice: from hemodynamic subsets to respirator settings. Intensive Care Med. 2003 Sep;29(9):1426-34. doi: 10.1007/s00134-003-1873-1. Epub 2003 Aug 9. No abstract available.
- Background: PubMed 2413570Alexi-Meskhisvili VV, Falkowski GE, Nikoljuk AP, Popov SA. Hemodynamic changes during mechanical ventilation in infants and small children after open heart surgery. Thorac Cardiovasc Surg. 1985 Aug;33(4):215-7. doi: 10.1055/s-2007-1014122.
- Background: PubMed 33991896Amaddeo A, Khraiche D, Khirani S, Meot M, Jais JP, Bonnet D, Fauroux B. Continuous positive airway pressure improves work of breathing in pediatric chronic heart failure. Sleep Med. 2021 Jul;83:99-105. doi: 10.1016/j.sleep.2021.04.003. Epub 2021 Apr 19.
- Background: PubMed 32556487Stohl S, Klein MJ, Ross PA, vonBusse S, Menteer J. Impact of Anesthetic and Ventilation Strategies on Invasive Hemodynamic Measurements in Pediatric Heart Transplant Recipients. Pediatr Cardiol. 2020 Jun;41(5):962-971. doi: 10.1007/s00246-020-02344-9. Epub 2020 Jun 18.
- Background: PubMed 32534648Eerdekens R, Bouwmeester S. Atrial septal defect and haemodynamic consequences of continuous positive airway pressure treatment. Lancet. 2020 Jun 13;395(10240):1864. doi: 10.1016/S0140-6736(20)31251-4. No abstract available.
- Background: PubMed 32730173Horn AG, Baumfalk DR, Schulze KM, Kunkel ON, Colburn TD, Weber RE, Bruells CS, Musch TI, Poole DC, Behnke BJ. Effects of elevated positive end-expiratory pressure on diaphragmatic blood flow and vascular resistance during mechanical ventilation. J Appl Physiol (1985). 2020 Sep 1;129(3):626-635. doi: 10.1152/japplphysiol.00320.2020. Epub 2020 Jul 30.
- Background: PubMed 10051276Michard F, Chemla D, Richard C, Wysocki M, Pinsky MR, Lecarpentier Y, Teboul JL. Clinical use of respiratory changes in arterial pulse pressure to monitor the hemodynamic effects of PEEP. Am J Respir Crit Care Med. 1999 Mar;159(3):935-9. doi: 10.1164/ajrccm.159.3.9805077.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Daniel Jimenez Santana, Resident principal investigator
University and Polytechnic Hospital La fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Perioperative/Postoperative Complications, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume challenge as a predictor of hemodynamic response to Open Lung Approach (time frame: At minute 5 after recruitment maneuver). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123039, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.