Efficacy and Ventilatory Responses to VHI in Atelectasis Patients

NCT02768350 | Completed DMC

• 1 other identifier: VHI-efficacy-atelectasis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Keywords

lung collapse; ventilator hyper inflation; hemodynamic responses; ventilatory responses; trauma patients

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Chest Radiography

  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.

  "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 (10)

• 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 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.

Study Arms (2)

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.

Procedure: Conventional treatment

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.

Procedure: Ventilator hyperinflation technique

Interventions

Ventilator hyperinflation technique PROCEDURE

Hyperinflation using a ventilator or "ventilator hyperinflation technique (VHI)" was developed from the manual hyperinflation (MHI) technique. There is no need to disconnect the patient when using the VHI technique and consequently there is no loss of PEEP and little or no risk of the adverse effects associated with MHI.

Experimental group

Conventional treatment PROCEDURE

Conventional treatments are the routine treatment that patients were received from the physical therapist who take care them. The routine treatments are consist of chest physical therapy techniques (i.e. vibration, positioning, etc.) and others treatment (i.e. passive movement).

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: school of physical therapy, faculty of associated medical sciences

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

TH (1)