Clinical trial NCT02768350: Efficacy and Ventilatory Responses to VHI in Atelectasis Patients
Official title: Efficacy and Ventilatory Responsiveness of Ventilator Hyperinflation Technique to Re-expand Lung Atelectasis and Improved Airway Clearance on Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: lung collapse
ventilator hyper inflation
hemodynamic responses
ventilatory responses
trauma patients
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study include (1) To investigate the efficacy of ventilator hyperinflation technique to re-expand lung atelectasis on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit, (2) To investigate the effectiveness of ventilator hyperinflation technique to improve airway clearance on patients with critical trauma in the intensive care unit, and (3) To explore the acute responses of ventilatory functions to ventilator hyperinflation technique on patients with critical trauma who intubated and mechanical ventilation in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Critical trauma patients with pulmonary complications who were intubated and mechanical ventilation and have a diagnosis of lobar atelectasis and/or plate-like atelectasis (atelectasis demonstrated on chest X-ray) will be considered for inclusion. For the sign of plate-like atelectasis will be persist on chest X-ray for 2 day
* The injuries may occur alone or combination of these injuries: 1) head injury, 2) chest injuries, including broken ribs, with or without hemothorax, pneumothorax and hemopneumothorax with intercostal chest drainage (ICD), 3) blunt abdominal, and 4) fracture of the limbs and/or spine.

Exclusion Criteria:

* acute respiratory distress syndrome (ARDS)
* acute lung injury (ALI)
* pulmonary contusion
* undrained pneumothorax, hemothorax, and hemopneumothorax
* bronchospasm
* pulmonary bullae/blebs
* lung tumors
* lung abscess
* haemoptysis
* mean arterial pressure (MAP) \<70 mmHg
* positive end expiratory pressure (PEEP) \>6 cmH2O
* heart rate (HR) \>140 beats/min
* blood pressure (BP) \<90/60 or \>180/100 mmHg
* restlessness
* oxygen saturation (SpO2) \<90%
* spontaneous respiratory rate (RR) \>35 beats/min

Primary outcomes:
measure: Change from Baseline in Chest Radiography
timeFrame: "Change from Baseline in Chest Radiography at Day 1 after Received Intervention (VHI)" and "Change from Baseline in Chest Radiography at Day 3 after Received Intervention (VHI)"
Secondary outcomes:
measure: Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in tidal volume (VT) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in oxygen saturation (SpO2) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in dynamic lung compliance (Cdyn) at during and end of ventilator hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in end-tidal pressure of carbon dioxide (PETCO2) at during and end of ventilator hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in peak inspiratory pressure (PIP) at during and end of ventilator hyperinflation technique (VHI)
timeFrame: Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
measure: Change from baseline in arterial blood gases (ABG) at end of ventilator hyperinflation technique (VHI)
timeFrame: Within one hour before VHI and 10 minute after VHI.
measure: 24 hour sputum collection
timeFrame: The secretion will be collected 24 hours in each day.
measure: Clearance index
timeFrame: Sputum content that collects at 08.30 and 09.35 will test by cough transportability method and compare between time point for represent the clearance index (at 08.30 for pre-intervention period and at 09.35 for post-intervention period).
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References: