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

NCT03141515 | Completed DMC

• 1 other identifier: HospitalPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Collapsed Lung

Keywords

lung ultrasound; recruitment maneuver; atelectasis; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Peripheral arterial oxygenation by pulse oximetry (SPO2%)

  Intraoperative

• Respiratory mechanics

  Intraoperative

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Recruitment maneuver group

EXPERIMENTAL

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

Interventions

Lung ultrasound DEVICE

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

Control group; Recruitment maneuver group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Privado de Comunidad de Mar del Plata: lead

Study Sites (1)

Cecilia M. Acosta

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cecilia M Acosta, MD

  Hospital Privado de Comunidad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 5, 2017
• Study Start: May 15, 2017
• Primary Completion: January 5, 2018
• Study Completion: January 5, 2018
• Last Updated: February 6, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)