Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.

Hypoxemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214312
• Other study ID #: B0762023231006
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Andrea Carini, MD
• Phone: +32 025354250
• Email: andreacarini1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atelectasis
• Hypoxemia
• Hypoxia
• Pulmonary Atelectasis

Intervention

Diagnostic Test:
• Lung Ultrasounds
An ultrasound exam of the lungs to identify possible areas of atelectasis.

Locations

Country	Name	City	State
Belgium	Chu St. Pierre	Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary aeration	Compare the Lung Aeration Score in the two groups	during surgery and in the immediate postoperative period
Secondary	Plethysmography	Correlation between Lung Aeration Score and Plethysmography	during surgery and in the immediate postoperative period.
Secondary	Ventilatory parameters	Correlation between Lung Aeration Score and Ventilatory parameters	during surgery