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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05418530
Acronym
expirapause
Enrollment
40
Registered
2022-06-14
Start date
2022-04-22
Completion date
2023-12-31
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency in Children

Keywords

Respiratory Insufficiency, respiratory artificial

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.

Interventions

OTHERwith pause- without pause

start with pause expiration

OTHERwithout pause-with pause

start without pause expiration

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Patients who meet the inclusion criteria and after signing the informed consent by the guardian will be randomized to closed system aspiration with an expiratory pause and closed system aspiration without an expiratory pause. Randomization will be performed by blocks of sealed envelopes, allocating the patient to a first technique to be performed and, after 6 hours, to another technique. All patients will perform both forms of aspiration and will be aspirated 2 hours before the start of each technique to match the groups.

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
secretion mass6 hoursThe secretion will be weighed on a scale graduated in milligrams.

Secondary

MeasureTime frameDescription
tidal volume6 hourstidal volume checked on the mechanical ventilator graduated in ml

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026