Hemodynamic Responses to Ventilator Hyperinflation Technique

June 5, 2024 updated by: Mr.Atsadang Natisri, Khon Kaen University

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Khon Kaen, Thailand, 40002
        • School of physical therapy, Faculty of Associated Medical Science, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Mechanical ventilator dependence

Exclusion Criteria:

  1. acute respiratory distress syndrome (ARDS)
  2. acute lung injury (ALI)
  3. pulmonary contusion
  4. undrained pneumothorax, hemothoarax, and hemopneumothorax
  5. bronchospasm
  6. pulmonary bullae/blebs
  7. lung tumors
  8. lung abscess
  9. haemoptysis
  10. mean arterial pressure (MAP) <70 mmHg
  11. positive end expiratory pressure (PEEP) >6 cm H2O
  12. heart rate (HR) > 140 beats/min
  13. blood pressure (BP) <90/60 or >180/100 mmHg
  14. restlessness
  15. oxygen saturation (SpO2) < 90 %
  16. spontaneous respiratory rate (RR) > 35 beats/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ventilator hyperinflation
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.
4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.
Experimental: Chest physical therapy
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.
The patient will be received vibration and passive of the both upper extremity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Change from baseline in heart rate (HR)
"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"
Change from baseline in systolic blood pressure (SBP)
"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"
Change from baseline in diastolic blood pressure (DBP)
"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"
Change from baseline in central venous pressure (CVP)
"change from baseline in central venous pressure (CVP) at during intervention" and "change from baseline in central venous pressure (CVP) at immediately after intervention"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Atsadang Natisri, Master, school of physical therapy, faculty of associated medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimated)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VHI-hemodynamic responses

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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