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Efficacy and Ventilatory Responses to VHI in Atelectasis Patients

Primary Purpose

Atelectasis

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Ventilator hyperinflation technique

Conventional treatment

About this trial

This is an interventional treatment trial for Atelectasis focused on measuring lung collapse, ventilator hyper inflation, hemodynamic responses, ventilatory responses, trauma patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)

Data will be recorded at 09.00, 09.02, 09.04, 09.06, 09.08, and 09.10 am for pre-intervention period, at 09.12, 09.14, 09.16, and 09.18 am for during intervention period (4 set of 6 VHI breath; each set take time about 2 min), and at 09.20, 09.24, 09.26, 09.28, and 09.30 am for post-intervention period. Data will be repeated record at the same time on day 2 and 3. Respiratory rate (RR) will be recorded from the display of mechanical ventilator.

Change from baseline in tidal volume (VT) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)

Change from baseline in minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)hyperinflation technique (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)

Change from baseline in dynamic lung compliance (Cdyn) at during and end of ventilator hyperinflation technique (VHI)

Change from baseline in end-tidal pressure of carbon dioxide (PETCO2) at during and end of ventilator hyperinflation technique (VHI)

Change from baseline in peak inspiratory pressure (PIP) at during and end of ventilator hyperinflation technique (VHI)

Change from baseline in arterial blood gases (ABG) at end of ventilator hyperinflation technique (VHI)

Data will be recorded at 08.00 and 09.10 am for pre-intervention and post-intervention, respectively. Five milliliter of arterial blood will be collected from arterial line (A-line) for the analysis of arterial blood gases analysis (ABG).

24 hour sputum collection

Endotracheal/tracheal suction will take at 08.30, 09.35, 11.00, 13.00, 15.00, 17.00, 19.00, 21.00, 23.00, 01.00, 03.00, 05.00, and 07.00 (24 hour). Sputum volume and wet weight at each time's collect will accumulate to represent for 24 hour sputum collection. The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water.

Clearance index

Full Information

NCT ID

NCT02768350

First Posted

February 2, 2016

Last Updated

March 8, 2018

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT02768350

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atelectasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Experimental

Arm Description

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Ventilator hyperinflation technique

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Conventional treatment

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change from Baseline in Chest Radiography

Description

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)"

Secondary Outcome Measure Information:

Title

Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)

Description

Time Frame