Tracheal Suctioning With or Without Expiratory Pause Maneuver in Children

July 22, 2024 updated by: Hospital de Clinicas de Porto Alegre

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

The purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight of endotracheal suctioning
Time Frame: Immediately after suctioning
Weight of endotracheal suctioning in milligrams
Immediately after suctioning

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Baseline, immediately after suctioning and after 30 minutes
Heart rate in beats per minute (bpm)
Baseline, immediately after suctioning and after 30 minutes
Arterial blood pressure
Time Frame: Baseline, immediately after suctioning and after 30 minutes
Systolic and diastolic blood pressure in millimeters of mercury (mmHg)
Baseline, immediately after suctioning and after 30 minutes
Oxygen saturation
Time Frame: Baseline, immediately after suctioning and after 30 minutes
Oxygen saturation in percentage (%)
Baseline, immediately after suctioning and after 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Bruna Ziegler, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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