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

Primary Purpose

Collapsed Lung

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Lung ultrasound
Sponsored by
Hospital Privado de Comunidad de Mar del Plata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Collapsed Lung focused on measuring lung ultrasound, recruitment maneuver, atelectasis, children

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cecilia M. Acosta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Recruitment maneuver group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
April 17, 2017
Last Updated
February 5, 2018
Sponsor
Hospital Privado de Comunidad de Mar del Plata
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1. Study Identification

Unique Protocol Identification Number
NCT03141515
Brief Title
Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia
Official Title
Sonographic Assessment of Postural Lung Recruitment in Pediatric Patients Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
January 5, 2018 (Actual)
Study Completion Date
January 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Privado de Comunidad de Mar del Plata

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collapsed Lung
Keywords
lung ultrasound, recruitment maneuver, atelectasis, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Recruitment maneuver group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lung ultrasound
Intervention Description
Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.
Primary Outcome Measure Information:
Title
Lung aeration
Description
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).
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Peripheral arterial oxygenation by pulse oximetry (SPO2%)
Description
The SPO2 % will be recorded before and after recruitment manoeuvre.
Time Frame
Intraoperative
Title
Respiratory mechanics
Description
Intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia M Acosta, MD
Organizational Affiliation
Hospital Privado de Comunidad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cecilia M. Acosta
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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