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Completed

NCT Number: NCT05805475

Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

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

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Key information

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal suctioning with expiratory pause

Other

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Endotracheal suctioning without expiratory pause

Other

Perform closed endotracheal suctioning without expiratory pause

Primary outcomes

  1. Weight of endotracheal suctioning

    Time frame: Immediately after suctioning

    Weight of endotracheal suctioning in milligrams

Secondary outcomes

  1. Peak inspiratory pressure

    Time frame: Baseline and 30 minutes

    Peak inspiratory pressure in centimeters of water (cmH2O)

  2. Plateau pressure

    Time frame: Baseline and 30 minutes

    Plateau pressure in centimeters of water (cmH2O)

  3. Tidal volume

    Time frame: Baseline and 30 minutes

    Tidal volume in milliliters (ml)

  4. Dynamic compliance

    Time frame: Baseline and 30 minutes

    Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)

  5. Airway resistance

    Time frame: Baseline and 30 minutes

    Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)

  6. Auto-positive end-expiratory pressure (auto-PEEP)

    Time frame: Baseline and 30 minutes

    Auto-PEEP in centimeters of water (cmH2O)

Other outcomes

  1. Heart rate

    Time frame: Baseline, immediately after suctioning and after 30 minutes

    Heart rate in beats per minute (bpm)

  2. Arterial blood pressure

    Time frame: Baseline, immediately after suctioning and after 30 minutes

    Systolic and diastolic blood pressure in millimeters of mercury (mmHg)

  3. Oxygen saturation

    Time frame: Baseline, immediately after suctioning and after 30 minutes

    Oxygen saturation in percentage (%)

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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