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Clinical Trials/NCT02768350
NCT02768350CompletedNot Applicable

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

Khon Kaen University2 sites in 1 country30 target enrollmentStarted: May 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change from Baseline in Chest Radiography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control group

Experimental

All of the participants in control group will be treated with conventional treatment for 3 days, The conventional treatments consist of: (1) Passive chest mobilization, (2) Positioning, (3) Side lying (good lung down), (4) Vibration. The conventional treatment consists of three consecutive periods; (1) baseline period: 10 minutes, (2) intervention period, and (3) recovery period: 10 minutes.

Intervention: Conventional treatment (Procedure)

Experimental group

Experimental

All of the participants of the experimental group will be treated with ventilator hyperinflation technique (VHI) for 3 days. Tidal volume will increase from baseline (100% VT) to the tidal volume target at 1.5 times (150% VT). At this level, patients will receive six breathes and in each breathe will be sustained for 5 second (6 hyperinflation breathe per set); expiratory VT will return to baseline after each breath. Four sets of hyperinflation breathing will be used. After this, VT will decrease to baseline and patients have a 60 second for rest between hyperinflation set. The ventilator hyperinflation technique (VHI) consists of three consecutive periods; (1) baseline period: 10 minutes, (2) intervention period, and (3) recovery period: 10 minutes.

Intervention: Ventilator hyperinflation technique (Procedure)

Outcomes

Primary Outcomes

Change from Baseline in Chest Radiography

Time Frame: "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)"

The study took three day, chest radiography will be taken at 2 day before the study begin (first film; base line) and after day 1 (second film) and day 3 of the study (third film). Any improvement will be assessed by comparing the second and the third film to the first film by a radiologist who will be blinded to the treatment given. Atelectasis will grade using the following rating scale: 0 = no atelectasis; 1 = plate-like atelectasis; 2 = mild lobar collapse; 3 = moderate lobar collapse; and 4 = complete lower lobar collapse. Separate results will comply for the left and right lungs.

Secondary Outcomes

  • Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in tidal volume (VT) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in peak inspiratory pressure (PIP) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in oxygen saturation (SpO2) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in dynamic lung compliance (Cdyn) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in end-tidal pressure of carbon dioxide (PETCO2) at during and end of ventilator hyperinflation technique (VHI)(Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.)
  • Change from baseline in arterial blood gases (ABG) at end of ventilator hyperinflation technique (VHI)(Within one hour before VHI and 10 minute after VHI.)
  • 24 hour sputum collection(The secretion will be collected 24 hours in each day.)
  • Clearance index(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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guntaragorn Hongrattana

school of physical therapy, faculty of associated medical sciences

Khon Kaen University

Study Sites (2)

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