Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia (AtelectLUS)

April 15, 2024 updated by: Anna Camporesi, Vittore Buzzi Children's Hospital

Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study

Children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. Aim of this study is to investigate the impact of inhalation versus intravenous induction on atelectasis formation during anesthesia induction in children. Atelectasis will be evaluated with lung ultrasound before induction and right after induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Respiratory complications, among which atelectasis, are a common cause of adverse events in pediatric anesthesia. Lung ultrasound (LUS) examination is a point of care, non-invasive, radiation-free tool with high sensitivity and specificity for the identification of anesthesia-induced atelectasis in children.

Inhalation induction is commonly performed in pediatric anesthesia to avoid pain at venipuncture or to facilitate vein cannulation. This technique has been associated with a higher rate of respiratory adverse events but no study has investigated the role of inhalation or intravenous induction on lung atelectasis development in pediatric anesthesia.

The investigators will perform this study aiming to describe the impact of inhalation versus intravenous induction technique on atelectasis formation during anesthesia induction in children of different ages.

Study Type

Observational

Enrollment (Actual)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20154
        • Vittore Buzzi Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children under 18 years of age scheduled for general anesthesia due to surgery.

Description

Inclusion Criteria:

  • scheduled for elective surgery under general anesthesia
  • parental consent

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status III-VI
  • neuromuscular disease
  • chronic lung disease
  • cardiopathy
  • thoracic cage malformations
  • chronic home ventilation (either invasive or non-invasive)
  • positive history of foreign body inhalation
  • required immediate life-saving procedures
  • lack of parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inhalatory induction
Patients who will be induced via mask with inhalators anesthetic gases
Other: Type of anesthesia induction
Patients will receive inhalatory or intravenous anesthesia at their choice; both groups will be evaluated with lung ultrasound after induction to detect ultrasonografic signs of atelectasis
Intravenous induction
Patients who will be induced with intravenous anesthetics
Other: Type of anesthesia induction
Patients will receive inhalatory or intravenous anesthesia at their choice; both groups will be evaluated with lung ultrasound after induction to detect ultrasonografic signs of atelectasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signs of atelectasis
Time Frame: Upon completion of induction and and subsequent controls at end of surgery and 1 postoperative day
Number of lung areas presenting a sub pleural consolidation
Upon completion of induction and and subsequent controls at end of surgery and 1 postoperative day
Global LUS score
Time Frame: Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day
Sum of the LUS scores given to all the lung areas. Score points vary from 0 to 3, where 0 means normality of the lung and 3 refers to complete loss of aeration-tissue-like pattern or consolidation.
Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vittore Buzzi Children's Hospital

Investigators

  • Study Director: Anna Camporesi, M.D., Vittore Buzzi Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/ST/147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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