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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

NCT05805475

Mechanical Ventilation Complication Pediatric Respiratory Diseases

COMPLETED NA

CPAP and Lateral Neck Rotation on Anesthetized Children

NCT00592423

Hypoventilation

TERMINATED NA

Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease

NCT05454215

Neuromuscular Diseases in Children

COMPLETED NA

Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

NCT01069185

Hypoxemia Arrhythmias Cardiac Arrest +1 more

COMPLETED NA

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

NCT02168387

Atelectasis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Insufficiency in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

with pause- without pause

Start with an expiratory pause during aspiration and after 6hours the aspiration is performed without an expiratory pause

Group Type ACTIVE_COMPARATOR

with pause- without pause

Intervention Type OTHER

start with pause expiration

without pause - with pause

Start without an expiratory pause during aspiration and after 6hours the aspiration is performed with an expiratory pause

Group Type ACTIVE_COMPARATOR

without pause-with pause

Intervention Type OTHER

start without pause expiration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

with pause- without pause

start with pause expiration

Intervention Type OTHER

without pause-with pause

start without pause expiration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No