Clinical trial NCT06214312: Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.
Official title: Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway: a Randomized Double-Blinded Controlled Trial That Compares Spontaneous and Pressure Support Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atelectasis
Hypoxemia
Keywords: lung ultrasounds
laryngeal mask airway
anesthetized children
spontaneous ventilation
pressure support ventilation
positive end expiratory pressure
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 43
Sex: MALE
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged between 12 months and 8 years scheduled for minor urologic surgery under general anesthesia.

Brief summary: This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.

Detailed description: It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.

Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.

Eligibility criteria: Inclusion Criteria:

* fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air \>96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.

Exclusion Criteria:

* ASA score \> II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.

Primary outcomes:
measure: Pulmonary aeration
timeFrame: during surgery and in the immediate postoperative period
Secondary outcomes:
measure: Plethysmography
timeFrame: during surgery and in the immediate postoperative period.
measure: Ventilatory parameters
timeFrame: during surgery
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Chu St. Pierre
state: Brussels
Study officials:
affiliation: Resident in Anesthesiology
name: Andrea Carini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Acosta CM, Lopez Vargas MP, Oropel F, Valente L, Ricci L, Natal M, Suarez Sipmann F, Tusman G. Prevention of atelectasis by continuous positive airway pressure in anaesthetised children: A randomised controlled study. Eur J Anaesthesiol. 2021 Jan;38(1):41-48. doi: 10.1097/EJA.0000000000001351.
citation: Fiedler MO, Schatzle E, Contzen M, Gernoth C, Weiss C, Walter T, Viergutz T, Kalenka A. Evaluation of Different Positive End-Expiratory Pressures Using Supreme Airway Laryngeal Mask during Minor Surgical Procedures in Children. Medicina (Kaunas). 2020 Oct 21;56(10):551. doi: 10.3390/medicina56100551.
citation: Joshi P, Vasishta A, Gupta M. Ultrasound of the pediatric chest. Br J Radiol. 2019 Aug;92(1100):20190058. doi: 10.1259/bjr.20190058. Epub 2019 May 16.
citation: Templeton TW, Hoke LK, Yaung J, Aschenbrenner CA, Rose DM, Templeton LB, Bryan YF. Comparing 3 ventilation modalities by measuring several respiratory parameters using the ProSeal laryngeal mask airway in children. J Clin Anesth. 2016 Nov;34:272-8. doi: 10.1016/j.jclinane.2016.04.031. Epub 2016 May 15.
citation: Lim B, Pawar D, Ng O. Pressure support ventilation vs spontaneous ventilation via ProSeal laryngeal mask airway in pediatric patients undergoing ambulatory surgery: a randomized controlled trial. Paediatr Anaesth. 2012 Apr;22(4):360-4. doi: 10.1111/j.1460-9592.2012.03819.x.
citation: von Goedecke A, Brimacombe J, Keller C, Hoermann C, Loeckinger A, Rieder J, Kleinsasser A. Positive pressure versus pressure support ventilation at different levels of PEEP using the ProSeal laryngeal mask airway. Anaesth Intensive Care. 2004 Dec;32(6):804-8. doi: 10.1177/0310057X0403200612.