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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06069414
Other study ID # 2022/ST/147
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date November 1, 2023

Study information

Verified date April 2024
Source Vittore Buzzi Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 326
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Vittore Buzzi Children's Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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