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

NCT ID: NCT04183309

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2022-07-29

Brief Summary

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.

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.

Conditions

Atelectasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric anesthetized patients

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

Measure the transpulmonary pressure in pediatric patients

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerardo Tusman, MD

Role: STUDY_DIRECTOR

Hospital Privado de Comunidad

Locations

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

2919/1980/2019

Identifier Type: -

Identifier Source: org_study_id