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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02208570
• Other study ID #: JHBahk_PPV_predictability
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2014
• Last updated: April 19, 2016
• Start date: July 2014

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: Jae-Hyon Bahk
• Phone: 82-2-2072-2818
• Email: bahkjh[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing general anesthesia induction with intravenous anesthesia using propofol and remifentanil

• Patients requiring invasive arterial blood pressure monitoring for the surgery

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

Other:
• PPV>14%
Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14

Drug:
• Volume loading
Hydroxyethyl starch solution 6ml/kg iv injection

Other:
• PPV<14%
Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation	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.	Three minutes after anesthesia agent injection	No
Secondary	Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before 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.	Three minutes before endotracheal intubation	No
Secondary	Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after 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.	Three minutes after endotracheal intubation	No