Effect of Closed Tracheal Aspiration Associated With Expiratory Pause in Pediatrics Randomized, Crossover Clinical Study

Not Applicable

• Conditions: Respiratory Insufficiency in Children
• Interventions: Other: without pause-with pause; Other: with pause- without pause

• Registration Number: NCT05418530
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

Introduction: Patients on mechanical ventilation suffer alterations in the viscoelastic characteristics of the mucus due to changes in the humidity and temperature of the inhaled air and in the respiratory volumes and flows. The literature has pointed out the use of mechanical ventilators as a tool for mobilizing secretions and closed-system aspiration associated with expiratory pause has been shown to be effective in mobilizing secretions. Objectives: To assess whether there is a difference in the mass of aspirated secretion with the application of the expiratory pause during aspiration. Methods: A crossover, randomized study. Applied to children aged 0 to 5 years and 11 months who are intubated for 24 hours with orotracheal tubes or tracheostomy. There will be an exclusion of patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study. The technique will be during aspiration in the tube with where to apply or not the expiratory pause on the mechanical ventilator. This secretion will be weighed so that there is fidelity in the results.

Detailed Description

A prospective, crossover, randomized clinical study will be carried out in the Pediatric ICU of Hospital Israelite Albert Einstein.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study Start: 2022-04-22
• Primary Completion: 2022-04-22
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients aged 0 to 5 years and 11 months who have been on invasive mechanical ventilation for more than 24 hours through an orotracheal cannula or tracheostomy will be included in the study.

Exclusion Criteria

• Patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
without pause - with pause	without pause-with pause	Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause
with pause- without pause	with pause- without pause	Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause

Primary Outcome Measures

Name	Time	Method
secretion mass	6 hours	The secretion will be weighed on a scale graduated in milligrams.

Secondary Outcome Measures

Name	Time	Method
tidal volume	6 hours	tidal volume checked on the mechanical ventilator graduated in ml

Trial Locations

Locations (1)

Albert Eisntein Hospital; 🇧🇷 São Paulo, Brazil