Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation
• Interventions: Other: 10-Second Expiratory Pause; Other: 5-Second Expiratory Pause

• Registration Number: NCT05579145
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-09-21
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10-Second Expiratory Pause	10-Second Expiratory Pause	Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds.
5-Second Expiratory Pause	5-Second Expiratory Pause	Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds.

Primary Outcome Measures

Name	Time	Method
Weight of secretion aspirated (grams)	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.

Secondary Outcome Measures

Name	Time	Method
Peripheral arterial oxygen saturation (SpO2) (%)	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.
Peak inspiratory pressure (PIP) (cm H2O)	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.
End expiratory pressure (PEEP) (cmH2O)	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.
Air trapping (AUTO-PEEP) (cmH2O)	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.
Mechanical ventilation circuit pressure (cmH2O)	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.
Tidal volume (TV) (ml)	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.
Endotracheal tube diameter (ETT) (mm)	One minute after the application of the studied technique.	The endotracheal tube diameter is directly written in the product package.
Dynamic compliance (Cd) (ml/cmH2O)	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.
Resistance (R) (L/s)	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.
Drive pressure (cmH2O)	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.
Heart rate (HR) (beats per minute)	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.
Respiratory rate (RR) (breaths per minute).	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.
Mean arterial pressure (MAP) (mmHg)	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.

Trial Locations

Locations (2)

Luciane FG Martins; 🇧🇷 Porto Alegre, RS, Brazil

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil