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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05805475
Other study ID # 2022-0072
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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