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Air Stacking Technique For Pulmonary Reexpansion

Sponsor
Hospital Nossa Senhora da Conceicao (Other)
Overall Status
Recruiting
CT.gov ID
NCT05702411
Collaborator
(none)
39
Enrollment
1
Location
2
Arms
20.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Air Stacking Technique
  • Other: No Air Stacking Technique
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Air Stacking Technique For Pulmonary Reexpansion In The Ventilator After Expiratory Pause During Aspiration In Closed System
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Tidal Volume (VT) (ml) [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.

Secondary Outcome Measures

  1. Weight of secretion aspirated (grams) [Immediately after the application of one of the protocols.]

    The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.

  2. Peripheral arterial oxygen saturation (SpO2) (%) [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.

  3. Peak inspiratory pressure (PIP) (cm H2O) [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.

  4. End expiratory pressure (PEEP) (cmH2O) [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.

  5. Air trapping (AUTO-PEEP) (cmH2O) [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.

  6. Mechanical ventilation circuit pressure (cmH2O) [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.

  7. Endotracheal tube diameter (ETT) (mm) [1-minute after the application of the studied technique.]

    The endotracheal tube diameter is directly written in the product package.

  8. Dynamic compliance (Cd) (ml/cmH2O) [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.

  9. Resistance (R) (L/s) [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.

  10. Drive pressure (cmH2O) [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.

  11. Heart rate (HR) (beats per minute) [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.

  12. Respiratory rate (RR) (breaths per minute) [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.

  13. Mean arterial pressure (MAP) (mmHg) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Cristo Redentor Porto Alegre RS Brazil 91040000

Sponsors and Collaborators

  • Hospital Nossa Senhora da Conceicao

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
NCT05702411
Other Study ID Numbers:
  • 50845721.0.0000.5530
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Nossa Senhora da Conceicao
pulmonary reexpansion
air stacking
mechanical ventilation

Study Results

No Results Posted as of Jan 27, 2023