Pulmonary ComplicationsNCT02739841
Hemodynamic Responses to Ventilator Hyperinflation Technique
A study testing Ventilator hyperinflation and Chest physical therapy in people with Pulmonary Complications, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Complications
- What is being tested?
- Ventilator hyperinflation and Chest physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to Apr 2017
- 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
- 1. Mechanical ventilator dependence
Who cannot join
- acute respiratory distress syndrome (ARDS)
- acute lung injury (ALI)
- pulmonary contusion
- undrained pneumothorax, hemothoarax, 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 cm H2O
- 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.
Thailand1 site
School of physical therapy, Faculty of Associated Medical Science, Khon Kaen University
Khon Kaen, 40002
About this study
Official title: Acute Hemodynamic Responses to Ventilator Hyperinflation Technique in Critical Traumatic Patients With Pulmonary Complications
The purpose of this study is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit.
Read the detailed description
The World Health Organization reported that Thailand ranked third for number of road fatalities at 38.1 per 100,000 inhabitants in 2010. Most of these cases were admitted to the intensive care unit (ICU) for respiratory interventions such as intubation and mechanical ventilation that can lead to a common problem of pulmonary complications such as pneumonia and atelectasis.
Evidence supports the effectiveness of chest physical therapy technique (CPT) to improve alveolar collapse and remove pulmonary secretion. A previous study has shown that the positive airway pressure technique reduced work of breathing (WOB) and re-inflated lung atelectasis. The use of positive pressure devices has been part of physiotherapy intervention since intermittent positive pressure breathing was introduced in clinical practice. In intensive care settings, the use of positive pressure by physiotherapists includes manual hyperinflation (bagging or bag squeezing), which has been shown to increase oxygenation and mobilize excessive bronchial secretions, and to re-inflate collapsed areas.
Manual hyperinflation technique (MHI) is provided for use in patients with lung atelectasis. Several studies demonstrated the short-term effects of increased oxygenation and pulmonary compliance, improved lung collapse, and removed pulmonary secretions. To apply MHI technique, patients were disconnected from the ventilator which lead to the adverse effect of losing positive end expiratory pressure (PEEP) corresponding to loss of functional residual capacity, decreased oxygenation, and shear stress of distal lung units.
An alternative method of performing pulmonary hyperinflation uses the mechanical ventilator. Although there is evidence that positive pressure interventions such as continuous positive airway pressure (CPAP) and intermittent positive pressure breathing IPPB) can improve lung expansion and mobilize secretions in the airway, there are few studies examining ventilator-induced hyperinflation as a physiotherapy intervention in intensive care.
A previous study showed that the ventilator hyperinflation technique (VHI) was as effective as MHI to improve pulmonary complications such as secretion retention and lung atelectasis. Especially, VHI technique using applied by the mechanical ventilator, patient was not disconnected from the ventilator and therefore did not result in loss of PEEP and its adverse effect.
Atelectasis is a common pulmonary complication in acute trauma patients maintained on ventilator support who would benefit from VHI but even though recent studies indicate that VHI technique is an improvement on the MHI technique there are relatively few study of the hemodynamic responses to VHI. There is controversy in hemodynamic responses to VHI, Ventilator hyperinflation technique (VHI) is especially valuable in treating patients in the ICU because other techniques such as percussion and postural drainage may not be possible because of wounds, broken bones or surgical drains. However, the technique is very rarely used by physical therapists in the ICU, possibly because they are concerned that increasing in the intra-thoracic pressure by uses VHI to inflate lung will result in dangerous changes in heart rate and blood pressure; that any such changes may persist after the treatment leading to complications such as pulmonary edema and, lastly, the positive pressure to the patient may precipitate episodes of cardiac arrhythmia.
Recent study demonstrated that heart rate and blood pressure were changed after VHI in ICU patients but the condition of patients in their study were mixed, not only traumatic patients. Previous study showed that basal heart and blood pressure were increased in patients underwent traumatic conditions. The hemodynamic responses to VHI were required for safety and increasing physiotherapist's confidences to use this technique in ICU. Therefore, the purpose of this study is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit.
- Conditions
- Pulmonary Complications
- Being tested
- Ventilator hyperinflation, Chest physical therapy
- Keywords
- hemodynamic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator hyperinflationOther
4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.
Chest physical therapyOther
The patient will be received vibration and passive of the both upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Ventilator hyperinflation | Experimental | For the ventilator hyperinflation techniques (VHI), the study consists of three consecutive periods 1) baseline period: 10 minutes rest in side lying by effected lung uppermost with head-up 30 degree 2) Intervention period: Patients were positioned as same as baseline period and 4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial 3) recovery period: 10 minutes rest in the same position but reduce VT to initial. Receives: Other: Ventilator hyperinflation |
| Chest physical therapy | Experimental | For the conventional chest physical therapy (CPT), the study will be performed in the similar procedure except the intervention period, the patient will be received vibration and passive of the both upper extremity. Receives: Other: Chest physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure (MAP)
Change from baseline in mean arterial pressure (MAP)
Measured: "change from baseline in mean arterial pressure (MAP) at during intervention" and "change from baseline in mean arterial pressure (MAP) at immediately after intervention"
Secondary outcomes (4)
Heart rate (HR)
Change from baseline in heart rate (HR)
Measured: "change from baseline in heart rate (HR) at during intervention" and "change from baseline in heart rate (HR) at immediately after intervention"
Systolic blood pressure (SBP)
Change from baseline in systolic blood pressure (SBP)
Measured: "change from baseline in systolic blood pressure (SBP) at during intervention" and "change from baseline in systolic blood pressure (SBP) at immediately after intervention"
Diastolic blood pressure (DBP)
Change from baseline in diastolic blood pressure (DBP)
Measured: "change from baseline in diastolic blood pressure (DBP) at during intervention" and "change from baseline in diastolic blood pressure (DBP) at immediately after intervention"
Central venous pressure (CVP)
Change from baseline in central venous pressure (CVP)
Measured: "change from baseline in central venous pressure (CVP) at during intervention" and "change from baseline in central venous pressure (CVP) at immediately after intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr.Atsadang Natisri, Khon Kaen University
- Investigators
- Atsadang Natisri, Master, Principal investigator, school of physical therapy, faculty of associated medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739841
- Sponsor's protocol ID
- VHI-hemodynamic responses
- Status last verified
- Jun 2024
- First submitted
- 28 Jan 2016
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Responses to Ventilator Hyperinflation Technique in Critical Traumatic Patients With Pulmonary Complications
- ClinicalTrials.gov ID
- NCT02739841
- Acronym / sponsor ID
- VHI-hemodynamic responses
- Conditions
- Pulmonary Complications
- Keywords
- hemodynamic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Apr 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 is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit.
Detailed description
The World Health Organization reported that Thailand ranked third for number of road fatalities at 38.1 per 100,000 inhabitants in 2010. Most of these cases were admitted to the intensive care unit (ICU) for respiratory interventions such as intubation and mechanical ventilation that can lead to a common problem of pulmonary complications such as pneumonia and atelectasis.
Evidence supports the effectiveness of chest physical therapy technique (CPT) to improve alveolar collapse and remove pulmonary secretion. A previous study has shown that the positive airway pressure technique reduced work of breathing (WOB) and re-inflated lung atelectasis. The use of positive pressure devices has been part of physiotherapy intervention since intermittent positive pressure breathing was introduced in clinical practice. In intensive care settings, the use of positive pressure by physiotherapists includes manual hyperinflation (bagging or bag squeezing), which has been shown to increase oxygenation and mobilize excessive bronchial secretions, and to re-inflate collapsed areas.
Manual hyperinflation technique (MHI) is provided for use in patients with lung atelectasis. Several studies demonstrated the short-term effects of increased oxygenation and pulmonary compliance, improved lung collapse, and removed pulmonary secretions. To apply MHI technique, patients were disconnected from the ventilator which lead to the adverse effect of losing positive end expiratory pressure (PEEP) corresponding to loss of functional residual capacity, decreased oxygenation, and shear stress of distal lung units.
An alternative method of performing pulmonary hyperinflation uses the mechanical ventilator. Although there is evidence that positive pressure interventions such as continuous positive airway pressure (CPAP) and intermittent positive pressure breathing IPPB) can improve lung expansion and mobilize secretions in the airway, there are few studies examining ventilator-induced hyperinflation as a physiotherapy intervention in intensive care.
A previous study showed that the ventilator hyperinflation technique (VHI) was as effective as MHI to improve pulmonary complications such as secretion retention and lung atelectasis. Especially, VHI technique using applied by the mechanical ventilator, patient was not disconnected from the ventilator and therefore did not result in loss of PEEP and its adverse effect.
Atelectasis is a common pulmonary complication in acute trauma patients maintained on ventilator support who would benefit from VHI but even though recent studies indicate that VHI technique is an improvement on the MHI technique there are relatively few study of the hemodynamic responses to VHI. There is controversy in hemodynamic responses to VHI, Ventilator hyperinflation technique (VHI) is especially valuable in treating patients in the ICU because other techniques such as percussion and postural drainage may not be possible because of wounds, broken bones or surgical drains. However, the technique is very rarely used by physical therapists in the ICU, possibly because they are concerned that increasing in the intra-thoracic pressure by uses VHI to inflate lung will result in dangerous changes in heart rate and blood pressure; that any such changes may persist after the treatment leading to complications such as pulmonary edema and, lastly, the positive pressure to the patient may precipitate episodes of cardiac arrhythmia.
Recent study demonstrated that heart rate and blood pressure were changed after VHI in ICU patients but the condition of patients in their study were mixed, not only traumatic patients. Previous study showed that basal heart and blood pressure were increased in patients underwent traumatic conditions. The hemodynamic responses to VHI were required for safety and increasing physiotherapist's confidences to use this technique in ICU. Therefore, the purpose of this study is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilator hyperinflation | Experimental | Other: Ventilator hyperinflationFor the ventilator hyperinflation techniques (VHI), the study consists of three consecutive periods 1) baseline period: 10 minutes rest in side lying by effected lung uppermost with head-up 30 degree 2) Intervention period: Patients were positioned as same as baseline period and 4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial 3) recovery period: 10 minutes rest in the same position but reduce VT to initial. |
| Chest physical therapy | Experimental | Other: Chest physical therapyFor the conventional chest physical therapy (CPT), the study will be performed in the similar procedure except the intervention period, the patient will be received vibration and passive of the both upper extremity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Mechanical ventilator dependence
Key exclusion criteria (16 listed)
- acute respiratory distress syndrome (ARDS)
- acute lung injury (ALI)
- pulmonary contusion
- undrained pneumothorax, hemothoarax, 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 hyperinflation4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial. | Other | Ventilator hyperinflation |
| Chest physical therapyThe patient will be received vibration and passive of the both upper extremity. | Other | Chest physical therapy |
Primary outcome
Mean arterial pressure (MAP)
Time frame: "change from baseline in mean arterial pressure (MAP) at during intervention" and "change from baseline in mean arterial pressure (MAP) at immediately after intervention"
Change from baseline in mean arterial pressure (MAP)
4 secondary outcomes
Heart rate (HR)
Time frame: "change from baseline in heart rate (HR) at during intervention" and "change from baseline in heart rate (HR) at immediately after intervention"
Systolic blood pressure (SBP)
Time frame: "change from baseline in systolic blood pressure (SBP) at during intervention" and "change from baseline in systolic blood pressure (SBP) at immediately after intervention"
Diastolic blood pressure (DBP)
Time frame: "change from baseline in diastolic blood pressure (DBP) at during intervention" and "change from baseline in diastolic blood pressure (DBP) at immediately after intervention"
Central venous pressure (CVP)
Time frame: "change from baseline in central venous pressure (CVP) at during intervention" and "change from baseline in central venous pressure (CVP) at immediately after intervention"
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 6 Jun 2024.
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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.
Atsadang Natisri, Master principal investigator
school of physical therapy, faculty of associated medical sciences
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 and Chest physical therapy in people with Pulmonary Complications, 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 1 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 6 Jun 2024. 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?
Mean arterial pressure (MAP) (time frame: "change from baseline in mean arterial pressure (MAP) at during intervention" and "change from baseline in mean arterial pressure (MAP) at immediately after intervention"). 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 6 Jun 2024.