NCT06069414

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

September 13, 2023

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Global LUS score

    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

  • Signs of atelectasis

    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

Study Arms (2)

Inhalatory induction

Patients who will be induced via mask with inhalators anesthetic gases

Other: Type of anesthesia induction

Intravenous induction

Patients who will be induced with intravenous anesthetics

Other: Type of anesthesia induction

Interventions

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

Inhalatory inductionIntravenous induction

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • scheduled for elective surgery under general anesthesia
  • parental consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vittore Buzzi Children's Hospital

Milan, 20154, Italy

Location

Related Publications (6)

  • Sargent MA, McEachern AM, Jamieson DH, Kahwaji R. Atelectasis on pediatric chest CT: comparison of sedation techniques. Pediatr Radiol. 1999 Jul;29(7):509-13. doi: 10.1007/s002470050632.

    PMID: 10398785BACKGROUND
  • Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.

    PMID: 24662376BACKGROUND
  • Zeng C, Lagier D, Lee JW, Vidal Melo MF. Perioperative Pulmonary Atelectasis: Part I. Biology and Mechanisms. Anesthesiology. 2022 Jan 1;136(1):181-205. doi: 10.1097/ALN.0000000000003943.

    PMID: 34499087BACKGROUND
  • Adler AC, Siddiqui A, Chandrakantan A, Matava CT. Lung and airway ultrasound in pediatric anesthesia. Paediatr Anaesth. 2022 Feb;32(2):202-208. doi: 10.1111/pan.14337. Epub 2021 Dec 1.

    PMID: 34797019BACKGROUND
  • de Graaff JC, Bijker JB, Kappen TH, van Wolfswinkel L, Zuithoff NP, Kalkman CJ. Incidence of intraoperative hypoxemia in children in relation to age. Anesth Analg. 2013 Jul;117(1):169-75. doi: 10.1213/ANE.0b013e31829332b5. Epub 2013 May 17.

  • Camporesi A, Roveri G, Vetrugno L, Buonsenso D, De Giorgis V, Costanzo S, Pierucci UM, Pelizzo G. Lung ultrasound assessment of atelectasis following different anesthesia induction techniques in pediatric patients: a propensity score-matched, observational study. J Anesth Analg Crit Care. 2024 Oct 5;4(1):69. doi: 10.1186/s44158-024-00206-x.

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Anna Camporesi, M.D.

    Vittore Buzzi Children's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 5, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations