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

Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183309
• Other study ID #: 2919/1980/2019
• Status: Completed
• Start date: January 6, 2020
• Est. completion date: July 29, 2022

Study information

• Verified date: February 2022
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Pneumoperitoneum
• Pulmonary Atelectasis

Intervention

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.

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	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	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