Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia

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.

Lung collapse is a pressure-dependent phenomenon. Each acinus has a critical closing pressure, i.e., the minimum transpulmonary pressure (Ptp) below that the acinus begins to collapse. While airway pressure is homogeneously distributed within all lung units, Pleural pressure increases along the vertical gravitational vector because of the lung's weight. As a consequence, the decreased Ptp in the dependent zones promotes collapse. This means that patients in the supine position suffer from increasing closing pressures in the ventral to dorsal direction.

Alveolar recruitment maneuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

The investigators hypothesized that in children with anesthesia-induced atelectasis, postural changes have recruiting effects and improve lung aeration assessed by lung ultrasound.

Study Overview

• Status: Completed
• Conditions: Collapsed Lung
• Intervention / Treatment: Device: Lung ultrasound

Detailed Description

Compare lung aeration between two different lung recruitment strategies (recruitment maneuvers in supine position and recruitment maneuvers with postural changes of lateral decubitus with 10 cmH2O level of positive-end expiratory pressure (PEEP) during 180 seconds; in pediatric patients scheduled for surgery under general anesthesia using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Cecilia M. Acosta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent by parents.
• Patients aged 6 months to 5 years old
• Scheduled for surgery under general anesthesia with tracheal intubation with atelectasis assessed by lung ultrasound after anesthesia induction.
• American Society of Anesthesiologists classification: physical status I-II

Exclusion Criteria:

• Acute airway infection
• Cardiovascular or pulmonary disease
• Previous thoracic procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; After anesthesia induction patients received lung recruitment maneuver using pressure-control ventilation with a patient in supine position with 10 cmH2O level of positive end-expiratory pressure PEEP during 180 seconds. Lung ultrasound examination will be performed at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.	Device: Lung ultrasound; Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.
Experimental: Recruitment maneuver group; Patients received lung recruitment maneuver with postural changes of lateral decubitus using pressure-control ventilation, 10 cmH2O level of PEEP in left and in right lateral decubitus during 90 seconds in each one. Lung ultrasound examination will be performed at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.	Device: Lung ultrasound; Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung aeration	Compare lung aeration between two different lung recruitment strategies (recruitment maneuvers in supine position with 10 cmH2O level of PEEP during 180 seconds and recruitment maneuvers with postural changes of lateral decubitus: 10 cmH2O level of PEEP in left and in right lateral decubitus during 90 seconds in each one) in pediatric patients scheduled for surgery under general anesthesia using ultrasound imaging and a four-point-aeration score to assess the lung aeration (0 = normal lung, 1 = moderate aeration loss, 2 = severe aeration loss, 3 = complete aeration loss and consolidation).	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral arterial oxygenation by pulse oximetry (SPO2%)	The SPO2 % will be recorded before and after recruitment manoeuvre.	Intraoperative
Respiratory mechanics	Intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance.	Intraoperative

Collaborators and Investigators

• Sponsor: Hospital Privado de Comunidad de Mar del Plata
• Investigators: Principal Investigator: Cecilia M Acosta, MD, Hospital Privado de Comunidad

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): January 5, 2018
• Study Completion (Actual): January 5, 2018

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: atelectasis; children; lung ultrasound; recruitment maneuver
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Pneumothorax; Pulmonary Atelectasis
• Other Study ID Numbers: HospitalPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No