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

NCT05737407 | Recruiting

• 1 other identifier: 2022ST251
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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. 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. 2.to determine if patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications in the first 24 hours.
3. 3.to compare static respiratory system compliance between groups.
4. 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.

Conditions

Oxygen Toxicity; Anesthesia; Adverse Effect

Keywords

Positive End Expiratory Pressure; Newborn; Atelectasis; Oxygen Toxicity; Lung Ultrasound

Outcome Measures

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

  During surgery

Secondary Outcomes (1)

• Incidence of Postoperative Pulmonary Complications in the first post-operative 24 hours

  In the first 24 hours after the intervention/procedure/surgery

Other Outcomes (2)

• Static compliance of the respiratory system between groups

  During surgery

• Need for fluids/vasopressors

  During surgery

Study Arms (2)

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%.

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%.

Other: Standard choice of Peep

Interventions

LUS-guided choice of Peep OTHER

Choice of Peep guided by lung ultrasound to avoid atelectasis

LUS-guided Peep

Standard choice of Peep OTHER

Choice of Peep according to standard practice

Standard setting of Peep

Eligibility Criteria

• Age: 33 Weeks - 50 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vittore Buzzi Children's Hospital: lead

Study Sites (1)

Vittore Buzzi Cildren's Hospital

Milan, 20154, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Anna Camporesi, MD

CONTACT

+393355793744; anna.camporesi@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 15, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)