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RecruitingNCT05737407Updated May 10, 2024

Lung Ultrasound Guided Choice of Best Positive End-Expiratory Pressure in Neonatal Anesthesia

An interventional study of LUS-guided choice of Peep and Standard choice of Peep in Oxygen Toxicity and Anesthesia; Adverse Effect, sponsored by Vittore Buzzi Children's Hospital. Recruiting at 1 site in Italy. Open to participants aged 33 Weeks to 50 Weeks. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Vittore Buzzi Children's Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
33 Weeks to 50 Weeks
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Oxygen Toxicity
  • Anesthesia; Adverse Effect

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Keywords

  • Positive End Expiratory Pressure
  • Newborn
  • Atelectasis
  • Oxygen Toxicity
  • Lung Ultrasound
03

In context

Pulmonary Atelectasis

377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.

This study's planned enrollment of 280 is above the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Vittore Buzzi Children's Hospital is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
33 Weeks to 50 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    LUS-guided Peep

    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%.

    Other: LUS-guided choice of Peep

  • Active comparator
    Standard setting of Peep

    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%.

    Other: Standard choice of Peep

Interventions

  • OtherLUS-guided choice of Peep

    Choice of Peep guided by lung ultrasound to avoid atelectasis

  • OtherStandard choice of Peep

    Choice of Peep according to standard practice

06

What researchers measure

Primary outcomes

  1. Change of FiO2 applied to the ventilatory setting in order to maintain same SpO2s.

    Difference between median SpO2/FiO2 ratio in the two groups

    Time frame: 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.

    Time frame: In the first 24 hours after the intervention/procedure/surgery

Other outcomes

  1. Static compliance of the respiratory system between groups

    Static respiratory system Compliance Crs ( ratio of Volume Variation ΔVol to Pressure Variation ΔP)

    Time frame: During surgery

  2. Need for fluids/vasopressors

    Need for fluid replacement and/or vasopressors in the intraoperative phase

    Time frame: During surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05737407
Lead sponsor
Vittore Buzzi Children's Hospital
Responsible party
Anna Camporesi (Principal Investigator, Vittore Buzzi Children's Hospital) — Principal investigator
First posted
Feb 21, 2023
Start date
Mar 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
May 10, 2024

Study contacts

Anna Camporesi, MD
Contact
anna.camporesi@asst-fbf-sacco.it
+393355793744

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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