Hemodynamic Responses to Ventilator Hyperinflation Technique

NCT ID: NCT02739841

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ventilator hyperinflation

Intervention Type: OTHER

4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.

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.

Group Type: EXPERIMENTAL

Chest physical therapy

Intervention Type: OTHER

The patient will be received vibration and passive of the both upper extremity.

Interventions

Ventilator hyperinflation

4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.

Intervention Type: OTHER

Chest physical therapy

The patient will be received vibration and passive of the both upper extremity.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Mr.Atsadang Natisri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atsadang Natisri, Master

Role: PRINCIPAL_INVESTIGATOR

school of physical therapy, faculty of associated medical sciences

Locations

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

Khon Kaen, , Thailand

Countries

Thailand

Other Identifiers

VHI-hemodynamic responses

Identifier Type: -

Identifier Source: org_study_id