AtelectasisNCT02768350
Efficacy and Ventilatory Responses to VHI in Atelectasis Patients
A study testing Ventilator hyperinflation technique and Conventional treatment in people with Atelectasis, run by Khon Kaen University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Ventilator hyperinflation technique and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- May 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- acute respiratory distress syndrome (ARDS)
- acute lung injury (ALI)
- pulmonary contusion
- undrained pneumothorax, hemothorax, and hemopneumothorax
- bronchospasm
- pulmonary bullae/blebs
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ventilator hyperinflation technique, Conventional treatment
- Keywords
- lung collapse, ventilator hyper inflation, hemodynamic responses, ventilatory responses, trauma patients
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator hyperinflation techniqueProcedure or surgery
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.
Conventional treatmentProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ventilator hyperinflation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: Within one hour before VHI and 10 minute after VHI.
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.
Measured: The secretion will be collected 24 hours in each day.
Clearance index
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guntaragorn Hongrattana, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768350
- Sponsor's protocol ID
- VHI-efficacy-atelectasis
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2016
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02768350
- Acronym / sponsor ID
- VHI-efficacy-atelectasis
- Conditions
- Atelectasis
- Keywords
- lung collapse, ventilator hyper inflation, hemodynamic responses, ventilatory responses, trauma patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: Conventional treatmentAll 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. |
| Experimental group | Experimental | Procedure: Ventilator hyperinflation techniqueAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- acute respiratory distress syndrome (ARDS)
- acute lung injury (ALI)
- pulmonary contusion
- undrained pneumothorax, hemothorax, and hemopneumothorax
- bronchospasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator hyperinflation techniqueHyperinflation 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. | Procedure or surgery | Experimental group |
| Conventional treatmentConventional 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). | Procedure or surgery | Control group |
Primary outcome
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.
10 secondary outcomes
Change from baseline in respiratory rate (RR) at during and end of ventilator hyperinflation technique (VHI)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Within one hour before VHI and 10 minute after VHI.
24 hour sputum collection
Time frame: The secretion will be collected 24 hours in each day.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator hyperinflation technique and Conventional treatment in people with Atelectasis, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.