Air Stacking Technique For Pulmonary Reexpansion

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702411
• Other study ID #: 50845721.0.0000.5530
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2023
• Source: Hospital Nossa Senhora da Conceicao
• Contact: Fernanda M Kutchak, Master
• Phone: +55 51 993196476
• Email: fernandakutchak[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care

Intervention

Other:
• Air Stacking Technique
Air Stacking lung reexpansion technique after aspiration with expiratory pause in a closed system.
• No Air Stacking Technique
Aspiration technique in a closed system of aspiration with an expiratory pause of 10 seconds.

Locations

Country	Name	City	State
Brazil	Hospital Cristo Redentor	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao

Country where clinical trial is conducted

Brazil, 

References & Publications (55)

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* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal Volume (VT) (ml)	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	Weight of secretion aspirated (grams)	The secretion aspirated into the collection flask will be weighed on a precision laboratory scale.	Immediately after the application of one of the protocols.
Secondary	Peripheral arterial oxygen saturation (SpO2) (%)	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.
Secondary	Peak inspiratory pressure (PIP) (cm H2O)	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.
Secondary	End expiratory pressure (PEEP) (cmH2O)	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.
Secondary	Air trapping (AUTO-PEEP) (cmH2O)	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.
Secondary	Mechanical ventilation circuit pressure (cmH2O)	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.
Secondary	Endotracheal tube diameter (ETT) (mm)	The endotracheal tube diameter is directly written in the product package.	1-minute after the application of the studied technique.
Secondary	Dynamic compliance (Cd) (ml/cmH2O)	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.
Secondary	Resistance (R) (L/s)	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.
Secondary	Drive pressure (cmH2O)	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.
Secondary	Heart rate (HR) (beats per minute)	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.
Secondary	Respiratory rate (RR) (breaths per minute)	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.
Secondary	Mean arterial pressure (MAP) (mmHg)	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.