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.

Study Overview

• Status: Completed
• Conditions: Atelectasis
• Intervention / Treatment: Other: Measure the transpulmonary pressure in pediatric patients

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Hospital Privado de Comunidad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 3 to 7 years old, schedule for abdominal laparoscopy surgery under general anesthesia with tracheal intubation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pediatric anesthetized patients; Pediatric anesthetized patients undergoing abdominal laparoscopy surgery (simple-arm study).

Other: Measure the transpulmonary pressure in pediatric patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transpulmonary pressure measured by esophageal ballon in pediatric patients	Effect of pneumoperitoneum on transpulmonary pressure using esophageal ballon in pediatric patients schedule for abdominal laparoscopy surgery.	2 hours

Collaborators and Investigators

• Sponsor: Hospital Privado de Comunidad de Mar del Plata
• Investigators: Study Director: Gerardo Tusman, MD, Hospital Privado de Comunidad

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Children
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Peritoneal Diseases; Pneumoperitoneum; Pulmonary Atelectasis
• Other Study ID Numbers: 2919/1980/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No