Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

Study Overview
=================
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.

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

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Other: 5-Second Expiratory Pause
* Other: 10-Second Expiratory Pause


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-Second Expiratory Pause<br>Closed system aspiration following by expiratory pause with mechanical ventilator for 5 seconds. | Other: 5-Second Expiratory Pause<br>* 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.<br>|
| Experimental: 10-Second Expiratory Pause<br>Closed system aspiration following by expiratory pause with mechanical ventilator for 10 seconds. | Other: 10-Second Expiratory Pause<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 closed system aspiration techniques. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral arterial oxygen saturation (SpO2) (%) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). | 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) | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchial hygiene, Tracheal suctioning, Respiratory therapy, Intensive care unit