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Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

Primary Purpose

Mechanical Ventilation Complication, Pediatric Respiratory Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endotracheal suctioning with expiratory pause
Endotracheal suctioning without expiratory pause
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mechanical Ventilation Complication focused on measuring Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endotracheal suctioning without expiratory pause

Endotracheal suctioning with expiratory pause

Arm Description

Conventional endotracheal suctioning in closed suction system

Endotracheal suctioning in closed suction system associated with expiratory pause maneuver

Outcomes

Primary Outcome Measures

Weight of endotracheal suctioning
Weight of endotracheal suctioning in milligrams

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2023
Last Updated
July 10, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05805475
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation Complication, Pediatric Respiratory Diseases
Keywords
Pediatric Critical Care, Respiratory Mechanics, Tracheal Suctioning, Mechanical ventilation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endotracheal suctioning without expiratory pause
Arm Type
Active Comparator
Arm Description
Conventional endotracheal suctioning in closed suction system
Arm Title
Endotracheal suctioning with expiratory pause
Arm Type
Experimental
Arm Description
Endotracheal suctioning in closed suction system associated with expiratory pause maneuver
Intervention Type
Other
Intervention Name(s)
Endotracheal suctioning with expiratory pause
Intervention Description
Perform closed endotracheal suctioning with an expiratory pause of 5 seconds
Intervention Type
Other
Intervention Name(s)
Endotracheal suctioning without expiratory pause
Intervention Description
Perform closed endotracheal suctioning without expiratory pause
Primary Outcome Measure Information:
Title
Weight of endotracheal suctioning
Description
Weight of endotracheal suctioning in milligrams
Time Frame
Immediately after suctioning
Secondary Outcome Measure Information:
Title
Peak inspiratory pressure
Description
Peak inspiratory pressure in centimeters of water (cmH2O)
Time Frame
Baseline and 30 minutes
Title
Plateau pressure
Description
Plateau pressure in centimeters of water (cmH2O)
Time Frame
Baseline and 30 minutes
Title
Tidal volume
Description
Tidal volume in milliliters (ml)
Time Frame
Baseline and 30 minutes
Title
Dynamic compliance
Description
Dynamic compliance in milliliters per kilograms per centimeters of water (mL/kg/cmH2O)
Time Frame
Baseline and 30 minutes
Title
Airway resistance
Description
Inspiratory and expiratory resistance in centimeters of water per liter (cmH2O/L)
Time Frame
Baseline and 30 minutes
Title
Auto-positive end-expiratory pressure (auto-PEEP)
Description
Auto-PEEP in centimeters of water (cmH2O)
Time Frame
Baseline and 30 minutes
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
Heart rate in beats per minute (bpm)
Time Frame
Baseline, immediately after suctioning and after 30 minutes
Title
Arterial blood pressure
Description
Systolic and diastolic blood pressure in millimeters of mercury (mmHg)
Time Frame
Baseline, immediately after suctioning and after 30 minutes
Title
Oxygen saturation
Description
Oxygen saturation in percentage (%)
Time Frame
Baseline, immediately after suctioning and after 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruna Ziegler
Phone
+5551 3359-7333
Email
bziegler@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Paula Peiter
Phone
+5551 3359-7334
Email
apeiter@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruna Ziegler
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Paula Peiter

12. IPD Sharing Statement

Plan to Share IPD
No

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Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

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