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Completed

NCT Number: NCT04183309

Effects of Pneumoperitoneum on Dynamic Alveolar Stress-strain in Anesthetized Pediatric Patients

General anesthesia is associated with loss of pulmonary functional residual capacity and consequent developement of atelectasis and closure of the small airway. Infants and young children are more susceptible to this lung collapse due to their small functional residual capacity.

Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain inducing a local inflammatory response in atelectatic lungs areas know as ventilatory induced-lung injury (VILI). This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes children to hypoxemic episodes that can persist in the early postoperative period. During laparoscopy, pneumoperitoneum may aggravate the reduction of functional residual capacity as it generates a further increase in intra-abdominal pressure.

The increase in alveolar stress-strain cloud be reduced during pneumoperitoneum in theory, if normal functional residual capacity is restored and the transpulmonary pression is reached at the end of expiration of 0-1 cmH2O.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

About this study

This is a prospective and observational study designed to measure transpulmonary pressure during pneumoperitoneum. The investigators will studied 20 mechanically ventilated pediatric patients schedule for abdominal laparoscopy surgery under general anesthesia.

Lung mechanics will be assessed during laparoscopy. Esophageal pressure will be measured by an esophageal ballon to measure transpulmonary pressure. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery. The optimal level of positive end-expiratory pressure (PEEP) if defined as the PEEP level when transpulmonary pressure remains positive during the PEEP titration trial of the recruitment maneuver.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written Inform Consent by parents
  • Programmed surgery
  • Laparoscopic surgery
  • Supine position
  • American Society of Anesthesiologists classification: physical status I-II

Exclusion criteria

  • Acute airway infection
  • Cardiovascular or pulmonary disease

Treatment and study plan

Measure the transpulmonary pressure in pediatric patients

Other

Esophageal pressure will be measured by an esophageal ballon to assess transpulmonary pressure during laparoscopy surgery. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. Lung ultrasound examinations will be performed at different times-points: after anesthesia induction, 10 minutes after pneumoperitoneum insufflation, and at the end of surgery. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery.

Primary outcomes

  1. Transpulmonary pressure measured by esophageal ballon in pediatric patients

    Time frame: 2 hours

    Effect of pneumoperitoneum on transpulmonary pressure using esophageal ballon in pediatric patients schedule for abdominal laparoscopy surgery.

Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2019
Registry last updated
Aug 29, 2022

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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