Clinical trial NCT06069414: Atelectasis After Inhalation or Intravenous Induction in Pediatric Anesthesia
Official title: Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Pediatric Anesthesia
Lead sponsor: Vittore Buzzi Children's Hospital
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 326
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 18 years of age scheduled for general anesthesia due to surgery.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global LUS score
timeFrame: Upon completion of induction and subsequent controls at end of surgery and 1 postoperative day
measure: Signs of atelectasis
timeFrame: Upon completion of induction and and subsequent controls at end of surgery and 1 postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Vittore Buzzi Children's Hospital
Study officials:
affiliation: Vittore Buzzi Children's Hospital
name: Anna Camporesi, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.