Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

November 1, 2022 updated by: Hospital de Clinicas de Porto Alegre

Effects of Combined Tracheal Suctioning and Expiratory Pause 5 or 10 Seconds: a Crossover Randomized Clinical Trial

A randomized crossover clinical trial conducted in an Intensive Care Unit of the Hospital de Clinicas de Porto Alegre (HCPA) to compare the efficacy of the two techniques on the amount of aspirated pulmonary secretion and pulmonary mechanics: aspiration of the closed system following an expiratory pause with mechanical ventilator for 5 seconds (5-Second Expiratory Pause) and aspiration of the closed system following an expiratory pause with mechanical ventilator for 10 seconds (10-Second Expiratory Pause).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After randomization, all patients will be positioned in dorsal decubitus with the head elevated at 30 degrees and will be aspirated once with a closed suction system and with a vacuum of -40cm H2O. Hemodynamic and pulmonary parameters will be collected and recorded. One of the two techniques will be applied, according to randomization, and the outcomes measured. After two hours, hemodynamic and pulmonary parameters will be re-collected, and the second technique will be applied. The outcomes will be measured again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Recruiting
        • Luciane FG Martins
        • Contact:
        • Contact:
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Luciane FG Martins, Master

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in 24 and 72 hours of mechanical ventilation.
  • Patients with closed aspiration system.
  • Patients hemodynamically stable (mean arterial blood pressure ≥ 60 mmHg and with dose of Noradrenaline ≤ 1μg/kg/minute).

Exclusion Criteria:

  • Undrained pneumothorax and hemothorax.
  • Subcutaneous emphysema.
  • Patients who refuse to participate in the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 5-Second Expiratory Pause
Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds.
Other: 5-Second Expiratory Pause
Patients on mechanical ventilation for more than 24 hours will be randomized for the first technique to be applied. This technique consists of closed system aspiration and expiratory pause with mechanical ventilator for 5 seconds. After randomization and before the application of the technique, all patients will be positioned in supine position with the headboard elevated at 30 degrees and will be aspirated once with closed aspiration system and with vacuum of -40 cm H2O.
Experimental: 10-Second Expiratory Pause
Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds.
Other: 10-Second Expiratory Pause
Patients on mechanical ventilation for more than 24 hours will be randomized for the first technique to be applied. This technique consists of closed system aspiration and expiratory pause with mechanical ventilator for 10 seconds. After randomization and before the application of the technique, all patients will be positioned in supine position with the headboard elevated at 30 degrees and will be aspirated once with closed aspiration system and with vacuum of -40 cm H2O.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight of secretion aspirated (grams)
Time Frame: Immediately after the application of one of the closed system aspiration techniques.
The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.
Immediately after the application of one of the closed system aspiration techniques.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peripheral arterial oxygen saturation (SpO2) (%)
Time Frame: One minute after the application of the studied technique.
After the 3-second expiratory pause on the mechanical ventilator, the SpO2 will be visualized on the monitor of the patient, and the value will be noted.
One minute after the application of the studied technique.
Peak inspiratory pressure (PIP) (cm H2O)
Time Frame: One minute after the application of the studied technique.
The PIP will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
End expiratory pressure (PEEP) (cmH2O)
Time Frame: One minute after the application of the studied technique.
The PEEP will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Air trapping (AUTO-PEEP) (cmH2O)
Time Frame: One minute after the application of the studied technique.
The AUTO-PEEP will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Mechanical ventilation circuit pressure (cmH2O)
Time Frame: One minute after the application of the studied technique.
The mechanical ventilation circuit pressure will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Tidal volume (TV) (ml)
Time Frame: One minute after the application of the studied technique.
The TV will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Endotracheal tube diameter (ETT) (mm)
Time Frame: One minute after the application of the studied technique.
The endotracheal tube diameter is directly written in the product package.
One minute after the application of the studied technique.
Dynamic compliance (Cd) (ml/cmH2O)
Time Frame: One minute after the application of the studied technique.
The Cd will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Resistance (R) (L/s)
Time Frame: One minute after the application of the studied technique.
The R will be visualized directly at mechanical ventilation monitor, and the value will be noted.
One minute after the application of the studied technique.
Drive pressure (cmH2O)
Time Frame: One minute after the application of the studied technique.
The drive pressure will be calculated by the difference between plateau pressure and positive end-expiratory pressure in the mechanical ventilation, and the value will be noted.
One minute after the application of the studied technique.
Heart rate (HR) (beats per minute)
Time Frame: One minute after the application of the studied technique.
After the 3-second expiratory pause on the mechanical ventilator, the HR will be visualized on the monitor of the patient, and the value will be noted.
One minute after the application of the studied technique.
Respiratory rate (RR) (breaths per minute).
Time Frame: One minute after the application of the studied technique.
After the 3-second expiratory pause on the mechanical ventilator, the RR will be visualized on the monitor of the patient, and the value will be noted.
One minute after the application of the studied technique.
Mean arterial pressure (MAP) (mmHg)
Time Frame: One minute after the application of the studied technique.
After the 3-second expiratory pause on the mechanical ventilator, the MAP will be calculated using the systolic and diastolic blood pressure, and the value will be noted.
One minute after the application of the studied technique.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciane FG Martins, Master, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 51995621.7.0000.5327

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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