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

Sponsor
Hospital Privado de Comunidad de Mar del Plata (Other)
Overall Status
Recruiting
CT.gov ID
NCT04183309
Collaborator
(none)
15
1
29.8
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 15 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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effects of Pneumoperitoneum on Dynamic Alveolar Stress-strain in Anesthetized Pediatric Patients
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Transpulmonary pressure measured by esophageal ballon in pediatric patients [2 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Privado de Comunidad Mar del Plata Buenos Aires Argentina 7600

Sponsors and Collaborators

  • Hospital Privado de Comunidad de Mar del Plata

Investigators

  • Study Director: Gerardo Tusman, MD, Hospital Privado de Comunidad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Privado de Comunidad de Mar del Plata
ClinicalTrials.gov Identifier:
NCT04183309
Other Study ID Numbers:
  • 2919/1980/2019
First Posted:
Dec 3, 2019
Last Update Posted:
Apr 13, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Privado de Comunidad de Mar del Plata
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022