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OpenTrials
Completed

NCT Number: NCT02824146

Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery

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. Such anesthesia-related atelectasis has a number of negative clinical consequences such as the impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for ventilator-associated lung injury. The adjustment of ventilator settings for preventing the occurrence of atelectasis and for reducing pulmonary complications remains controversial.

Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including atelectasis of different origins. LUS has demonstrated its high sensitivity and specificity for diagnosing anesthesia-induced atelectasis in children.

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Key information

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Compare lung aeration between two different mechanical ventilation strategies (protective mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent by parents.
  • Patients aged 6 months to 7 years old
  • Scheduled for abdominal laparoscopic surgery
  • American Society of Anesthesiologists classification: physical status I-II

Exclusion criteria

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

Treatment and study plan

Lung Recruitment Maneuver

Other

The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (15 cmH2O of PEEP + 15 cmH2O of driving pressure) for 10 breaths.

Primary outcomes

  1. Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score to assess the lung aeration

    Time frame: intraoperative

    Compare lung aeration between protective mechanical ventilation and recruitment maneuvers in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four point aeration score (0: normal lung aeration, 1: moderate loss of lung aeration, 2: severe loss of lung aeration, 3: complete loss of lung aeration and lung consolidation).

Secondary outcomes

  1. Lung aeration score pre/post the recruitment maneuver during laparoscopic surgery

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Official study title

Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Abdominal Laparoscopic Surgery

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Jul 6, 2016

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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