Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805475
• Other study ID #: 2022-0072
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Bruna Ziegler
• Phone: +5551 3359-7333
• Email: bziegler[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Pediatric Respiratory Diseases
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Endotracheal suctioning with expiratory pause
Perform closed endotracheal suctioning with an expiratory pause of 5 seconds
• Endotracheal suctioning without expiratory pause
Perform closed endotracheal suctioning without expiratory pause

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	Heart rate in beats per minute (bpm)	Baseline, immediately after suctioning and after 30 minutes
Other	Arterial blood pressure	Systolic and diastolic blood pressure in millimeters of mercury (mmHg)	Baseline, immediately after suctioning and after 30 minutes
Other	Oxygen saturation	Oxygen saturation in percentage (%)	Baseline, immediately after suctioning and after 30 minutes
Primary	Weight of endotracheal suctioning	Weight of endotracheal suctioning in milligrams	Immediately after suctioning
Secondary	Peak inspiratory pressure	Peak inspiratory pressure in centimeters of water (cmH2O)	Baseline and 30 minutes
Secondary	Plateau pressure	Plateau pressure in centimeters of water (cmH2O)	Baseline and 30 minutes
Secondary	Tidal volume	Tidal volume in milliliters (ml)	Baseline and 30 minutes
Secondary	Dynamic compliance	Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)	Baseline and 30 minutes
Secondary	Airway resistance	Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)	Baseline and 30 minutes
Secondary	Auto-positive end-expiratory pressure (auto-PEEP)	Auto-PEEP in centimeters of water (cmH2O)	Baseline and 30 minutes