Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

NCT ID: NCT05805475

Last Updated: 2024-07-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

Detailed Description

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After being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. Children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied.

Clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen).

The protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmHg for all the participants. After two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. Respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques.

In case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation \< 85%, heart rate \> 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.

Conditions

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Mechanical Ventilation Complication Pediatric Respiratory Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Endotracheal suctioning without expiratory pause

Conventional endotracheal suctioning in closed suction system

Group Type ACTIVE_COMPARATOR

Endotracheal suctioning without expiratory pause

Intervention Type OTHER

Perform closed endotracheal suctioning without expiratory pause

Endotracheal suctioning with expiratory pause

Endotracheal suctioning in closed suction system associated with expiratory pause maneuver

Group Type EXPERIMENTAL

Endotracheal suctioning with expiratory pause

Intervention Type OTHER

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Interventions

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Endotracheal suctioning with expiratory pause

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Intervention Type OTHER

Endotracheal suctioning without expiratory pause

Perform closed endotracheal suctioning without expiratory pause

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children at invasive mechanical ventilation for more than 24 hours;
* Under the effect of neuromuscular blocker (level of sedation assessed using the Comfort B Scale with a score \<10 and without a cough reflex);
* Endotracheal suctioning in a period \> 2h before the application of the technique.

Exclusion Criteria

* Patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema;
* Hemodynamic instability (hypotension refractory to treatment)
* Need of frequent endotracheal suctioning
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruna Ziegler

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2022-0072

Identifier Type: -

Identifier Source: org_study_id

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