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

Collapsed Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141515
• Other study ID #: HospitalPC
• Status: Completed
• Phase: N/A
• First received: April 17, 2017
• Last updated: February 5, 2018
• Start date: May 15, 2017
• Est. completion date: January 5, 2018

Study information

• Verified date: May 2017
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Collapsed Lung
• Pneumothorax
• Pulmonary Atelectasis

Intervention

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

Locations

Country	Name	City	State
Argentina	Cecilia M. Acosta	Mar del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

Outcome

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