Clinical trial NCT02824146: Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery
Official title: Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Abdominal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: atelectasis
children
lung ultrasound
lung recruitment
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery. Such anesthesia-related atelectasis has a number of negative clinical consequences such as the impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for ventilator-associated lung injury. The adjustment of ventilator settings for preventing the occurrence of atelectasis and for reducing pulmonary complications remains controversial.

Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including atelectasis of different origins. LUS has demonstrated its high sensitivity and specificity for diagnosing anesthesia-induced atelectasis in children.

Detailed description: Compare lung aeration between two different mechanical ventilation strategies (protective mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Eligibility criteria: Inclusion Criteria:

* Written informed consent by parents.
* Patients aged 6 months to 7 years old
* Scheduled for abdominal laparoscopic surgery
* American Society of Anesthesiologists classification: physical status I-II

Exclusion Criteria:

* Acute airway infection
* Cardiovascular and or pulmonary disease
* Previous thoracic procedure

Primary outcomes:
measure: Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score to assess the lung aeration
timeFrame: intraoperative
Secondary outcomes:
measure: Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Privado de Comunidad
name: Cecilia Maria Acosta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
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: Serafini G, Cornara G, Cavalloro F, Mori A, Dore R, Marraro G, Braschi A. Pulmonary atelectasis during paediatric anaesthesia: CT scan evaluation and effect of positive endexpiratory pressure (PEEP). Paediatr Anaesth. 1999;9(3):225-8. doi: 10.1046/j.1460-9592.1999.00340.x.
citation: Tusman G, Bohm SH, Vazquez de Anda GF, do Campo JL, Lachmann B. 'Alveolar recruitment strategy' improves arterial oxygenation during general anaesthesia. Br J Anaesth. 1999 Jan;82(1):8-13. doi: 10.1093/bja/82.1.8.
citation: Acosta CM, Sara T, Carpinella M, Volpicelli G, Ricci L, Poliotto S, Abrego D, Gonorazky S, Bohm SH, Tusman G. Lung recruitment prevents collapse during laparoscopy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):573-580. doi: 10.1097/EJA.0000000000000761.