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

NCT06214312 | Completed

• 1 other identifier: B0762023231006
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis; Hypoxemia

Keywords

lung ultrasounds; laryngeal mask airway; anesthetized children; spontaneous ventilation; pressure support ventilation; positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

• Pulmonary aeration

  Compare the Lung Aeration Score in the two groups

  during surgery and in the immediate postoperative period

Secondary Outcomes (2)

• Plethysmography

  during surgery and in the immediate postoperative period.

• Ventilatory parameters

  during surgery

Study Arms (2)

Spontaneous ventilation

Anesthetized Children ventilated with a laryngeal mask airway in spontaneous ventilation with a positive end expiratory pressure of 5cmH2O.

Diagnostic Test: Lung Ultrasounds

Pressure support ventilation

Anesthetized Children ventilated with a laryngeal mask airway in pressure support ventilation with a positive end expiratory pressure of 5cmH2O, maximum pressure not exceeding 15cmH2O.

Diagnostic Test: Lung Ultrasounds

Interventions

Lung Ultrasounds DIAGNOSTIC_TEST

An ultrasound exam of the lungs to identify possible areas of atelectasis.

Pressure support ventilation; Spontaneous ventilation

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged between 12 months and 8 years scheduled for minor urologic surgery under general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Chu St. Pierre

Brussels, Brussels Capital, 1000, Belgium

Location

Related Publications (7)

• 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.

  PMID: 24662376 BACKGROUND

• 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.

  PMID: 33009190 BACKGROUND

• 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.

  PMID: 33096743 BACKGROUND

• 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.

  PMID: 31095416 BACKGROUND

• 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.

  PMID: 27687391 BACKGROUND

• 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.

  PMID: 22380745 BACKGROUND

• 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.

  PMID: 15648991 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Carini, MD

  Resident in Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion: April 30, 2024
• Study Completion: June 23, 2024
• Last Updated: February 13, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)