CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Tidal Volume Challenge +1 moreother
Likely dose
Not stated in record
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Search/NCT06123039
NCT06123039N/ACompleted

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

Hospital Universitario La Fe·observational·Posted Nov 8, 2023·Updated Apr 2, 2025

In Brief

An observational study evaluating Tidal Volume Challenge and Recruitment maneuver obtaining individualised PEEP for Anesthesia and 3 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed 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. 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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedNov 8, 2023
Enrollment StartNov 6, 2023
Primary CompletionFeb 28, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.6 years ago

Interventions

Tidal Volume Challengeother

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

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.