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Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05805475
Enrollment
10
Registered
2023-04-10
Start date
2023-04-01
Completion date
2024-06-30
Last updated
2024-07-23

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

Conditions

Mechanical Ventilation Complication, Pediatric Respiratory Diseases

Keywords

Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation

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.

Interventions

OTHEREndotracheal suctioning with expiratory pause

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

OTHEREndotracheal suctioning without expiratory pause

Perform closed endotracheal suctioning without expiratory pause

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weight of endotracheal suctioningImmediately after suctioningWeight of endotracheal suctioning in milligrams

Secondary

MeasureTime frameDescription
Tidal volumeBaseline and 30 minutesTidal volume in milliliters (ml)
Dynamic complianceBaseline and 30 minutesDynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)
Airway resistanceBaseline and 30 minutesInspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)
Auto-positive end-expiratory pressure (auto-PEEP)Baseline and 30 minutesAuto-PEEP in centimeters of water (cmH2O)
Peak inspiratory pressureBaseline and 30 minutesPeak inspiratory pressure in centimeters of water (cmH2O)
Plateau pressureBaseline and 30 minutesPlateau pressure in centimeters of water (cmH2O)

Other

MeasureTime frameDescription
Oxygen saturationBaseline, immediately after suctioning and after 30 minutesOxygen saturation in percentage (%)
Heart rateBaseline, immediately after suctioning and after 30 minutesHeart rate in beats per minute (bpm)
Arterial blood pressureBaseline, immediately after suctioning and after 30 minutesSystolic and diastolic blood pressure in millimeters of mercury (mmHg)

Countries

Brazil

Outcome results

None listed

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