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

NCT ID: NCT03141515

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-01-05

Brief Summary

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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

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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.

Conditions

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Collapsed Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

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.

Group Type EXPERIMENTAL

Lung ultrasound

Intervention Type DEVICE

Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

Interventions

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Lung ultrasound

Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cecilia M Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Comunidad

Locations

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Cecilia M. Acosta

Mar del Plata, Buenos Aires, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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HospitalPC

Identifier Type: -

Identifier Source: org_study_id

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