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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
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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)
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 minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)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 oxygen saturation (SpO2) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)technique (VHI)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 dynamic lung compliance (Cdyn) 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 end-tidal pressure of carbon dioxide (PETCO2) 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 peak inspiratory pressure (PIP) 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 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

First Posted
February 2, 2016
Last Updated
March 8, 2018
Sponsor
Khon Kaen University
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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
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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 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
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.
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
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in tidal volume (VT) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in minute ventilation (VE) at during and end of ventilator hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in oxygen saturation (SpO2) at during and end of ventilator hyperinflation technique (VHI)hyperinflation technique (VHI)technique (VHI)hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in dynamic lung compliance (Cdyn) at during and end of ventilator hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in end-tidal pressure of carbon dioxide (PETCO2) at during and end of ventilator hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in peak inspiratory pressure (PIP) at during and end of ventilator hyperinflation technique (VHI)
Description
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.
Time Frame
Within 10 minutes before VHI, 8 minutes during VHI and 10 minute after VHI.
Title
Change from baseline in arterial blood gases (ABG) at end of ventilator hyperinflation technique (VHI)
Description
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).
Time Frame
Within one hour before VHI and 10 minute after VHI.
Title
24 hour sputum collection
Description
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.
Time Frame
The secretion will be collected 24 hours in each day.
Title
Clearance index
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

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Efficacy and Ventilatory Responses to VHI in Atelectasis Patients

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