Atelectasis Clinical Trial
— AtelectLUSOfficial title:
Atelectasis Evaluated With Lung Ultrasound After Inhalation or Intravenous Induction in Pediatric Anesthesia: a Prospective, Observational, Propensity Scored Matched Study
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 |
Verified date | April 2024 |
Source | Vittore Buzzi Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Vittore Buzzi Children's Hospital | Milan |
Lead Sponsor | Collaborator |
---|---|
Vittore Buzzi Children's Hospital |
Italy,
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
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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