NCT06123039Completed
Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 72 (actual)
- First submitted
- 5 Nov 2023
- Start date
- 6 Nov 2023
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Hospital Universitario La Fe
- Diseases
- Stroke
- NCT number
- NCT06123039
What you commit to
- Study type: Observational
- Participants enrolled: 72
- From 6 Nov 2023 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.