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NCT Number: NCT03141515

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.

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Key information

Conditions

Collapsed Lung Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cecilia M. Acosta

Mar del Plata, Buenos Aires, 7600, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung ultrasound

Device

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

Primary outcomes

  1. Lung aeration

    Time frame: Intraoperative

    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 outcomes

  1. Peripheral arterial oxygenation by pulse oximetry (SPO2%)

    Time frame: Intraoperative

    The SPO2 % will be recorded before and after recruitment manoeuvre.

  2. Respiratory mechanics

    Time frame: Intraoperative

    Intra-operative ventilator data will be recorded to measure respiratory mechanics such as dynamic and statistic compliance.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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