Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737407
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-02-09
Brief Title:
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia
Sponsor:
Vittore Buzzi Childrens Hospital
Organization:
Vittore Buzzi Childrens Hospital
Study Overview
Official Title:
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this RCT is to demonstrate that in neonatal anesthesia the use of Lung Ultrasound LUS to guide choice of best Positive End-Expiratory Pressure Peep - the one that efficiently avoids lung atelectasis - leads to better gas exchange in the lung thus can lead to reduction of FiO2 applied to ventilatory setting in order to achieve same peripheral saturations of oxygen SpO2
Specific aims of the study are
1 to determine if LUS-guided PEEP choice in neonatal anesthesia compared to standard PEEP choice can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s
2 to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours
3 to compare static respiratory system compliance between groups
4 to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups
Specific aims of the study are
1 to determine if LUS-guided PEEP choice in neonatal anesthesia compared to standard PEEP choice can lead to reduction of FiO2 applied to the ventilatory setting in order to maintain same SpO2s
2 to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours
3 to compare static respiratory system compliance between groups
4 to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups
Detailed Description:
The investigators plan to perform a single-center randomised controlled trial in compliance with the Helsinki Declaration and local regulatory agreements Patients of age under two months scheduled for general anesthesia due to elective or urgent surgery will be eligible for enrolment Eligible cases will be treated by only two experienced anesthesiologists with more than 10-year experience in pediatric field who underwent a formal LUS training in order to reduce operator-dependency of the results Parental consent to the study will be obtained before entering operatory room
Both groups will be preliminarily scanned with LUS in the posterior areas before induction of anesthesia upon entrance into the operatory theatre Posterior areas of the chest will be defined as the area between the posterior axillary line and the spine not including the scapular area This will be further categorized into Upper and Lower as divided by an imaginary line passing through the nipples so that 4 posterior areas are identified Right Upper Zone Right Lower Zone Left Upper Zone Left Lower zone For every zone presence of multiple B lines and subpleural consolidations will be noted The same ultrasound machine will be used for all cases
In both groups a standard tidal volume of 6 mlkg and a standard respiratory rate of 30min will be applied after anesthesia induction and endotracheal intubation
Patients will be randomised through the Stata software randomizer just before entering operatory room into one of the 2 following groups
Intervention group after induction of anesthesia and intubation patients will be briefly turned onto their side and LUS will be performed in the posterior areas of the lung PEEP will be adjusted in increments of 1 cmH20minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations andor multiple B lines are not present anymore
Control group after induction patients will be similarly scanned with LUS on their side but PEEP will be set at 4 cmH2O independently from results of LUS
FiO2 will be chosen as the minimum necessary to maintain SpO2 of 97-98 in both groups
Demographic and surgical data will be collected for both groups Intraoperatively patients will be monitored with standard monitoring systems SpO2 Heart Rate Blood Pressure diuresis temperature plus NIRS Near-Infrared-Spectroscopy these data will be recorded every 5 minutes Ventilator settings will also be recorded every 5 minutes Changes in PEEP or FiO2 needed according to clinical data or need for recruitment manoeuvres will be noted with relative time of occurrence Major intraoperative complications such as desaturation 90 hypotension 5th percentile for age bradycardia80 bpm will be noted Static compliance will be measured after final PEEP is applied and recorded Postoperatively occurrence of PPC in the first 24 hours will be recorded
Blinding the anesthesiologist in charge of the case wont be blinded to the group as heshe is the person who will perform LUS and set PEEP and FiO2 for the case After surgery the personnel in the ward or ICU will be blinded to the arm of the study and will record postoperative pulmonary complications Parents of patients will be blinded too
Both groups will be preliminarily scanned with LUS in the posterior areas before induction of anesthesia upon entrance into the operatory theatre Posterior areas of the chest will be defined as the area between the posterior axillary line and the spine not including the scapular area This will be further categorized into Upper and Lower as divided by an imaginary line passing through the nipples so that 4 posterior areas are identified Right Upper Zone Right Lower Zone Left Upper Zone Left Lower zone For every zone presence of multiple B lines and subpleural consolidations will be noted The same ultrasound machine will be used for all cases
In both groups a standard tidal volume of 6 mlkg and a standard respiratory rate of 30min will be applied after anesthesia induction and endotracheal intubation
Patients will be randomised through the Stata software randomizer just before entering operatory room into one of the 2 following groups
Intervention group after induction of anesthesia and intubation patients will be briefly turned onto their side and LUS will be performed in the posterior areas of the lung PEEP will be adjusted in increments of 1 cmH20minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations andor multiple B lines are not present anymore
Control group after induction patients will be similarly scanned with LUS on their side but PEEP will be set at 4 cmH2O independently from results of LUS
FiO2 will be chosen as the minimum necessary to maintain SpO2 of 97-98 in both groups
Demographic and surgical data will be collected for both groups Intraoperatively patients will be monitored with standard monitoring systems SpO2 Heart Rate Blood Pressure diuresis temperature plus NIRS Near-Infrared-Spectroscopy these data will be recorded every 5 minutes Ventilator settings will also be recorded every 5 minutes Changes in PEEP or FiO2 needed according to clinical data or need for recruitment manoeuvres will be noted with relative time of occurrence Major intraoperative complications such as desaturation 90 hypotension 5th percentile for age bradycardia80 bpm will be noted Static compliance will be measured after final PEEP is applied and recorded Postoperatively occurrence of PPC in the first 24 hours will be recorded
Blinding the anesthesiologist in charge of the case wont be blinded to the group as heshe is the person who will perform LUS and set PEEP and FiO2 for the case After surgery the personnel in the ward or ICU will be blinded to the arm of the study and will record postoperative pulmonary complications Parents of patients will be blinded too
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