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

NCT05418530 — Not applicable, Unknown, 40 participants, Hospital Israelita Albert Einstein

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05418530, acronym expirapause
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, supportive care
Enrollment	40 (Estimated)
Sponsor	Hospital Israelita Albert Einstein (Other)
Conditions	Respiratory Insufficiency in Children
Interventions	with pause- without pause, without pause-with pause (Other)
Dates	start 2022-04-22, primary completion 2022-04-22, completion 2023-12-01 (estimated), first posted 2022-06-14, last updated 2022-06-14
Locations	1 site in Brazil

-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.

Expand all sections · Collapse all

+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
with pause- without pause	Active comparator	Other: with pause- without pause	Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause
without pause - with pause	Active comparator	Other: 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 (Other): start with pause expiration
without pause-with pause (Other): start without pause expiration

+Outcome measures

Primary outcomes

secretion mass [6 hours]: The secretion will be weighed on a scale graduated in milligrams.

Secondary outcomes

tidal volume [6 hours]: tidal volume checked on the mechanical ventilator graduated in ml

+Eligibility

Sex: All, ages: any to 5 Years

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.

+Locations (1)

Facility	City	Country	Status
Albert Eisntein Hospital	São Paulo	Brazil	Recruiting