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

NCT04183309 | Completed DMC

• 1 other identifier: 2919/1980/2019
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Keywords

Children; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pediatric anesthetized patients

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

Other: Measure the transpulmonary pressure in pediatric patients

Interventions

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.

Pediatric anesthetized patients

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• Acute airway infection
• Cardiovascular or pulmonary disease

Sponsors & Collaborators

• Hospital Privado de Comunidad de Mar del Plata: lead

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerardo Tusman, MD

  Hospital Privado de Comunidad

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: January 6, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)