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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Thailand

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.

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 groups in NCT02739841
Study groupRoleWhat they receive
Ventilator hyperinflationExperimentalFor 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 therapyExperimentalFor 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.

  1. 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)
  1. 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"

  2. 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"

  3. 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"

  4. 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.

  1. First posted15 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

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)
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

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.

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