Air Stacking Technique For Pulmonary Reexpansion

January 25, 2023 updated by: Hospital Nossa Senhora da Conceicao

Air Stacking Technique For Pulmonary Reexpansion In The Ventilator After Expiratory Pause During Aspiration In Closed System

A cross-over randomized clinical trial carried out at the Intensive Care Unit. Patients who are on mechanical ventilation for more than 24 hours will be included in the study. The following techniques will be applied: aspiration in a closed system with an expiratory pause of 10 seconds associated to hyperinflation maneuver with a mechanical ventilator with the Air Stacking technique and aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 limited to 150 cmH2O.

Two hours later, hemodynamic and ventilatory parameters will be collected and recorded.

If randomized to Protocol 1 (Air Stacking technique), the aspiration technique with closed system and expiratory pause will be performed three times during a 30-second interval, with a probe of the same caliber and the same vacuum value. One ml of saline solution will be instilled in the aspiration system to washing the closed suction circuit.

Immediately after, the Air Stacking maneuvers will be performed. If Protocol 2 (No Air Stacking technique), only tracheal suction with closed system.

Hemodynamic and ventilatory parameters will be collected after 1, 10 and 30 minutes of application. The secretions aspirated into the collection flasks will then be weighed, on a precision balance, by a collaborator blinded that is not part of the study, and the weight will be transcribed to the data collect.

Study Type

Interventional

Enrollment (Anticipated)

39

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 Contact

Study Contact Backup

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 91040000
        • Recruiting
        • Hospital Cristo Redentor
        • Contact:
        • Contact:
          • Fernanda M Kutchak, Master
          • Phone Number: +5551993196476

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 18 years or older
  • patients on mechanical ventilation for more than 48 hours
  • patients on volume or pressure controlled ventilatory mode
  • patients hemodynamically stable (equal mean blood pressure or more than 60 mmHg, and dose of Norepinephrine less than 1μg / Kg / minute)
  • patients whose legal representatives authorize participation in the study.

Exclusion Criteria:

  • undrained pneumothorax and hemothorax, and emphysema subcutaneous
  • fracture of ribs
  • ventilatory parameters with peak pressure greater than 40 cm/H2O

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
Intervention / Treatment
Experimental: Protocol 1
Closed system aspiration with an expiratory pause of 10 seconds followed by hyper insufflation maneuver with the Air Stacking technique.
Other: Air Stacking Technique
Air Stacking lung reexpansion technique after aspiration with expiratory pause in a closed system.
Experimental: Protocol 2
Closed system aspiration with an expiratory pause of 10 seconds.
Other: No Air Stacking Technique
Aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal Volume (VT) (ml)
Time Frame: At 30-minute after the application of the studied technique.
The tidal volume will be visualized directly at mechanical ventilation monitor. Variations in tidal volume will be considered before and after the interventions.
At 30-minute after the application of the studied technique.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight of secretion aspirated (grams)
Time Frame: Immediately after the application of one of the protocols.
The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.
Immediately after the application of one of the protocols.
Peripheral arterial oxygen saturation (SpO2) (%)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The SpO2 will be visualized on the monitor of the patient, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Peak inspiratory pressure (PIP) (cm H2O)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The PIP will be visualized directly at mechanical ventilation monitor, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
End expiratory pressure (PEEP) (cmH2O)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The PEEP will be visualized directly at mechanical ventilation monitor, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Air trapping (AUTO-PEEP) (cmH2O)
Time Frame: 1, 10 and 30-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.
1, 10 and 30-minute after the application of the studied technique.
Mechanical ventilation circuit pressure (cmH2O)
Time Frame: 1, 10 and 30-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.
1, 10 and 30-minute after the application of the studied technique.
Endotracheal tube diameter (ETT) (mm)
Time Frame: 1-minute after the application of the studied technique.
The endotracheal tube diameter is directly written in the product package.
1-minute after the application of the studied technique.
Dynamic compliance (Cd) (ml/cmH2O)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The Cd will be visualized directly at mechanical ventilation monitor, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Resistance (R) (L/s)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The R will be visualized directly at mechanical ventilation monitor, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Drive pressure (cmH2O)
Time Frame: 1, 10 and 30-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.
1, 10 and 30-minute after the application of the studied technique.
Heart rate (HR) (beats per minute)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The HR will be visualized on the monitor of the patient, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Respiratory rate (RR) (breaths per minute)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The RR will be visualized on the monitor of the patient, and the value will be noted.
1, 10 and 30-minute after the application of the studied technique.
Mean arterial pressure (MAP) (mmHg)
Time Frame: 1, 10 and 30-minute after the application of the studied technique.
The MAP will be calculated using the systolic and diastolic blood pressure, and the value will be noted.
1, 10 and 30-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

Hospital Nossa Senhora da Conceicao

Investigators

  • Principal Investigator: Fernanda M Kutchak, Master, Grupo Hospitalar Conceição

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)

September 1, 2021

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 50845721.0.0000.5530

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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