Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06123039
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-11-05
Brief Title:
Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Sponsor:
Hospital Universitario La Fe
Organization:
Hospital Universitario La Fe
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiPEEP
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 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
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
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 patients 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 heshe will be included for data collection If heshe benefits from a recruitment manoeuvre air-test clinical indication which will be assessed by clinical indications heshe 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 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 dPdtMAX should always be performed Patients who do not have optimal arterial waveform morphology at this point will be excluded
2 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
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
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 patients 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 heshe will be included for data collection If heshe benefits from a recruitment manoeuvre air-test clinical indication which will be assessed by clinical indications heshe 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 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 dPdtMAX should always be performed Patients who do not have optimal arterial waveform morphology at this point will be excluded
2 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None