Clinical trial NCT05805475: Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children
Official title: Effects of Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children Submitted to Invasive Mechanical Ventilation: a Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Pediatric Respiratory Diseases
Keywords: Pediatric Critical Care
Respiratory Mechanics
Tracheal Suctioning
Mechanical ventilation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight of endotracheal suctioning
timeFrame: Immediately after suctioning
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: Baseline and 30 minutes
measure: Plateau pressure
timeFrame: Baseline and 30 minutes
measure: Tidal volume
timeFrame: Baseline and 30 minutes
measure: Dynamic compliance
timeFrame: Baseline and 30 minutes
measure: Airway resistance
timeFrame: Baseline and 30 minutes
measure: Auto-positive end-expiratory pressure (auto-PEEP)
timeFrame: Baseline and 30 minutes
Other outcomes:
measure: Heart rate
timeFrame: Baseline, immediately after suctioning and after 30 minutes
measure: Arterial blood pressure
timeFrame: Baseline, immediately after suctioning and after 30 minutes
measure: Oxygen saturation
timeFrame: Baseline, immediately after suctioning and after 30 minutes
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Bruna Ziegler
role: PRINCIPAL_INVESTIGATOR
References: