Predictability of the Pulse Pressure Variation (PPV) During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia

Not Applicable

• Conditions: Hypotension
• Interventions: Other: PPV>14%; Drug: Volume loading; Other: PPV<14%

• Registration Number: NCT02208570
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to find out the predictability of the pulse pressure variation during spontaneous ventilation on the incidence of hypotension during induction of anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil
• Patients requiring invasive arterial blood pressure monitoring for the surgery

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Exclusion Criteria

• Refusal of consent
• Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt, pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)
• FEV1 ≤ 50% predicted FEV1
• Patients with chronic renal failure
• ASA class IV, V, VI
• Systolic arterial blood pressure below 90mmHg before induction of anesthesia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P(+)V(+)	PPV>14%	PPV\>14% before anesthesia induction, HES 6ml/kg infused
P(+)V(+)	Volume loading	PPV\>14% before anesthesia induction, HES 6ml/kg infused
P(+)V(-)	PPV>14%	PPV\>14% before anesthesia induction, no additional volume infused
P(-)V(+)	Volume loading	PPV\<14% before anesthesia induction, HES 6ml/kg infused
P(-)V(+)	PPV<14%	PPV\<14% before anesthesia induction, HES 6ml/kg infused
P(-)V(-)	PPV<14%	PPV\<14% before anesthesia induction, no additional volume infused

Primary Outcome Measures

Name	Time	Method
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation	Three minutes after anesthesia agent injection	First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure.; At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.

Secondary Outcome Measures

Name	Time	Method
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation	Three minutes after endotracheal intubation	We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes after endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation	Three minutes before endotracheal intubation	We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes before endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of