Oxygen ToxicityNCT05737407
Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia
A study testing LUS-guided choice of Peep and Standard choice of Peep in people with Oxygen Toxicity and Anesthesia; Adverse Effect, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 33 to 50 weeks
- Conditions the study is for
- Oxygen Toxicity, Anesthesia; Adverse Effect
- What is being tested?
- LUS-guided choice of Peep and Standard choice of Peep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 15 Dec 2024
- Phase
- Interventional
- 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 33 to 50 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients born after 33 weeks of gestationand up to the age of 50 post-conceptional weeks undergoing elective or urgent surgery requiring general anesthesia with endotracheal intubation
Who cannot join
- born at less than 33 weeks of gestation
- patients with signs or symptoms of cardiac or lung abnormalities or diseases
- patients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditions
- no parental consent is obtained
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vittore Buzzi Cildren's Hospital
Milan, 20154
Anna Camporesi, MD, anna.camporesi@asst-fbf-sacco.it
About this study
Official title: Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia: a Randomized, Controlled Trial
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:
- 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.
- to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.
- to compare static respiratory system compliance between groups.
- to determine if there is a significant difference in hemodynamic parameters and amount of fluids infused or need for vasopressors between the two groups.
Read the 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 ml/kg and a standard respiratory rate of 30/min 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 cmH20/minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations and/or 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, bradycardia<80 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 won't be blinded to the group as he/she 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.
- Conditions
- Oxygen Toxicity, Anesthesia; Adverse Effect
- Being tested
- LUS-guided choice of Peep, Standard choice of Peep
- Keywords
- Positive End Expiratory Pressure, Newborn, Atelectasis, Oxygen Toxicity, Lung Ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUS-guided choice of PeepOther
Choice of Peep guided by lung ultrasound to avoid atelectasis
Standard choice of PeepOther
Choice of Peep according to standard practice
| Study group | Role | What they receive |
|---|---|---|
| LUS-guided Peep | Experimental | 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 cmH20/minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations and/or multiple B lines are not present anymore.
FiO2 will be chosen as the minimum necessary to maintain SpO2 of 97-98%. Receives: Other: LUS-guided choice of Peep |
| Standard setting of Peep | Active comparator | 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%. Receives: Other: Standard choice of Peep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
Difference between median SpO2/FiO2 ratio in the two groups
Measured: During surgery
Secondary outcomes (1)
Incidence of Postoperative Pulmonary Complications in the first post-operative 24 hours
Comparison of incidence of desaturation (arterial oxyhemoglobin saturation measured with pulsoxymetry < 90% measured and requiring oxygen therapy), need for unplanned postoperative invasive or non invasive ventilation, pneumonia between groups.
Measured: In the first 24 hours after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen ToxicityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vittore Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Camporesi, Vittore Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737407
- Sponsor's protocol ID
- 2022ST251
- Status last verified
- May 2024
- First submitted
- 9 Feb 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05737407
- Acronym / sponsor ID
- 2022ST251
- Conditions
- Oxygen Toxicity, Anesthesia; Adverse Effect
- Keywords
- Positive End Expiratory Pressure, Newborn, Atelectasis, Oxygen Toxicity, Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Vittore Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 21 Feb 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.
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:
- 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.
- to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.
- to compare static respiratory system compliance between groups.
- 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 ml/kg and a standard respiratory rate of 30/min 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 cmH20/minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations and/or 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, bradycardia<80 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 won't be blinded to the group as he/she 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUS-guided Peep | Experimental | Other: LUS-guided choice of PeepAfter 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 cmH20/minute starting from zero while maintaining visual inspection of LUS up to the point where signs of eventual subpleural consolidations and/or multiple B lines are not present anymore. FiO2 will be chosen as the minimum necessary to maintain SpO2 of 97-98%. |
| Standard setting of Peep | Active comparator | Other: Standard choice of PeepAfter 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%. |
Who may qualify
- Ages
- 33 to 50 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients born after 33 weeks of gestationand up to the age of 50 post-conceptional weeks undergoing elective or urgent surgery requiring general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- born at less than 33 weeks of gestation
- patients with signs or symptoms of cardiac or lung abnormalities or diseases
- patients with suspected/confirmed immune diseases, known or suspected metabolic or genetic conditions
- no parental consent is obtained
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 |
|---|---|---|
| LUS-guided choice of PeepChoice of Peep guided by lung ultrasound to avoid atelectasis | Other | LUS-guided Peep |
| Standard choice of PeepChoice of Peep according to standard practice | Other | Standard setting of Peep |
Primary outcome
Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.
Time frame: During surgery
Difference between median SpO2/FiO2 ratio in the two groups
1 secondary outcome
Incidence of Postoperative Pulmonary Complications in the first post-operative 24 hours
Time frame: In the first 24 hours after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUS-guided choice of Peep and Standard choice of Peep in people with Oxygen Toxicity and Anesthesia; Adverse Effect, run by Vittore Buzzi Children's Hospital at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Camporesi, MD (+393355793744, anna.camporesi@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.