AtelectLUS: Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia

Sponsor
Vittore Buzzi Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06069414
Collaborator
(none)
100
1
8
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Type of anesthesia induction

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Global LUS score [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 4, where 0 means normality of the lung and 4 refers to serious compromise of normal ultrasound normality.

  2. Signs of atelectasis [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vittore Buzzi Children's Hospital Milan Italy 20154

Sponsors and Collaborators

  • Vittore Buzzi Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anna Camporesi, Principal Investigator, Vittore Buzzi Children's Hospital
ClinicalTrials.gov Identifier:
NCT06069414
Other Study ID Numbers:
  • 2022/ST/147
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023