Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05805475

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Complication Pediatric Respiratory Diseases	Other: Endotracheal suctioning with expiratory pause Other: Endotracheal suctioning without expiratory pause	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endotracheal suctioning without expiratory pause Conventional endotracheal suctioning in closed suction system	Other: Endotracheal suctioning without expiratory pause Perform closed endotracheal suctioning without expiratory pause
Experimental: Endotracheal suctioning with expiratory pause Endotracheal suctioning in closed suction system associated with expiratory pause maneuver	Other: Endotracheal suctioning with expiratory pause Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Arm

Intervention/Treatment

Active Comparator: Endotracheal suctioning without expiratory pause

Conventional endotracheal suctioning in closed suction system

Other: Endotracheal suctioning without expiratory pause

Perform closed endotracheal suctioning without expiratory pause

Experimental: Endotracheal suctioning with expiratory pause

Endotracheal suctioning in closed suction system associated with expiratory pause maneuver

Other: Endotracheal suctioning with expiratory pause

Perform closed endotracheal suctioning with an expiratory pause of 5 seconds

Outcome Measures

Primary Outcome Measures

Weight of endotracheal suctioning [Immediately after suctioning]
Weight of endotracheal suctioning in milligrams

Secondary Outcome Measures

Peak inspiratory pressure [Baseline and 30 minutes]
Peak inspiratory pressure in centimeters of water (cmH2O)
Plateau pressure [Baseline and 30 minutes]
Plateau pressure in centimeters of water (cmH2O)
Tidal volume [Baseline and 30 minutes]
Tidal volume in milliliters (ml)
Dynamic compliance [Baseline and 30 minutes]
Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)
Airway resistance [Baseline and 30 minutes]
Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)
Auto-positive end-expiratory pressure (auto-PEEP) [Baseline and 30 minutes]
Auto-PEEP in centimeters of water (cmH2O)

Other Outcome Measures

Heart rate [Baseline, immediately after suctioning and after 30 minutes]
Heart rate in beats per minute (bpm)
Arterial blood pressure [Baseline, immediately after suctioning and after 30 minutes]
Systolic and diastolic blood pressure in millimeters of mercury (mmHg)
Oxygen saturation [Baseline, immediately after suctioning and after 30 minutes]
Oxygen saturation in percentage (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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