Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome

NCT ID: NCT01716962

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30

Brief Summary

Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in response to volume load.Low tidal volume and high PEEP exerts contrast effect on the prediction of fluid responsiveness, the aim of this study is to compare the relative predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress syndrome ventilated with various PEEP levels or various tidal volumes.

Detailed Description

In septic critically ill mechanically ventilated patients with acute circulatory failure, inadequate volume resuscitation leads to multiple organ failure. Early goal-directed therapy emphasizes early and aggressive hemodynamic support in patients with severe sepsis and septic shock. On the other hand, because of increased microvascular permeability and capillary leakage, conservative fluid management and more aggressive restriction in fluid accumulation to reduce lung water and tissue edema has been suggested by acute respiratory distress syndrome net. Fluid responsiveness refers to the ability of the heart to increase its stroke volume in response to volume load. Accurately predicting volume responsiveness will be beneficial in obviating the need for unnecessary fluid loading, and in detecting patients who may benefit from a volume load.

By inducing cyclic changes in pleural and transpulmonary pressure, mechanical ventilation results in cyclic changes in the preload and afterload, and therefore, the cyclic variation in systolic and pulse pressure. Recently, a systemic review concluded that dynamic preload indicator [pulse pressure variation (PPV), stroke volume variation (SVV)] are highly accurate in predicting volume responsiveness in critically ill patients. However, this technique is limited to patients who receive controlled ventilation with adequate tidal volume (> 8 ml/Kg) and sedation or paralysis is needed to abolish the spontaneous ventilation.

For acute respiratory distress syndrome patients, protective ventilatory strategy suggested low tidal volume to 6 ml/Kg. On the contrary, high PEEP needed for acute respiratory distress syndrome to prevent VALI induces a leftward shift to the steep pat of the Frank-Starling curve and increase the fluid responsiveness. Whether the dynamic preload indicators (PPV and SVV) are still effective in acute respiratory distress syndrome patients for predicting fluid responsiveness remain controversial.

Passive leg raising (PLR), by inducing a gravitational transfer of blood from the lower part of the body toward the central circulatory compartment, can be considered as a brief "self volume challenge". Recently, a systemic review and meta-analysis concluded that PLR-induced changes in cardiac output reliably predict fluid responsiveness regardless of ventilation mode, underlying cardiac rhythm and technique of measurement and can be recommended for routine assessment of fluid responsiveness in the majority of ICU population. More importantly, this prediction remains very valuable in patients with cardiac arrhythmias or spontaneous breathing activity.

Respiratory variations in the pulse oximeter plethysmographic waveform amplitude (ΔPOP) have been shown to be able to predict fluid responsiveness in mechanically ventilated patients. The main advantage of this index is that it is noninvasive, widely available, and inexpensive. Perfusion index (PI), the percentage between the infrared pulsatile and nonpulsatile signal, reflects the amplitude of the pulse oximeter waveform. Recently, Pleth Variability Index (PVI), derived from perfusion index, affords a continuous monitoring of ΔPOP. PVI has been shown to be correlated to ΔPOP and PPV and has been demonstrated to be equivalent to SVV as a predictor of fluid responsiveness in ventilated patients during major surgery. However, whether the PVI can predict the fluid responsiveness in acute respiratory distress syndrome necessitating low tidal volume and high PEEP is not clear.

Because of the aforementioned contrasting effects of low tidal volume and high PEEP on the prediction of fluid responsiveness, the aim of this study is to compare the relative predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and PVI on the fluid responsiveness of acute respiratory distress syndrome ventilated with various PEEP levels or various tidal volumes.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute respiratory distress syndrome, Fluid responsiveness, Pulse pressure variation; Pleth variability index, Passive leg raising test

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ARDS with acute circulatory failure

acute respiratory distress syndrome with acute circulatory failure with infusion of 6% tetrastarch for a total of 500ml

Infusion of 6% tetrastarch for a total of 500 ml

Intervention Type: OTHER

Interventions

Infusion of 6% tetrastarch for a total of 500 ml

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. systolic blood pressure< 9 mmHg(or a decrease > 50 mmHg in previously hypertensive patients)

2. need of vasopressive drugs(dopamine > 5 ug/Kg/min or norepinephrine)

3. urine output<0.5 mL/Kg/hr for at least 2 hrs

4. tachycardia (heart rate >100/min)

5. presence of skin mottling.

Exclusion Criteria

1. patient with spontaneous respiratory activity

2. cardiac arrhythmia

3. known intracardiac shunt

4. contraindication for passive leg raising(PLR),e.g.,pelvic trauma

5. unstable spine injuries or leg amputation

6. hemodynamic instability during the procedure,defined by a variation in heart rate or blood pressure of>10%over the 15-min period before starting the protocol

7. Patients of renal failure necessitate renal replacement therapy will be excluded also.

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

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huang chung chi

Director of Department of Respiratory Therapy, Chang Gung University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chung-Chi Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Facility Contacts

Chung-Chi Huang, MD

Role: primary

Other Identifiers

CGMF IRB 100-4473A3

Identifier Type: -

Identifier Source: org_study_id