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

NCT02208570 | Unknown

• 1 other identifier: JHBahk_PPV_predictability
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Hypotension during anesthesia induction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation

  Three minutes before endotracheal intubation

• Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation

  Three minutes after endotracheal intubation

Study Arms (4)

P(+)V(+)

EXPERIMENTAL

PPV\>14% before anesthesia induction, HES 6ml/kg infused

Other: PPV>14%; Drug: Volume loading

P(+)V(-)

EXPERIMENTAL

PPV\>14% before anesthesia induction, no additional volume infused

Other: PPV>14%

P(-)V(+)

EXPERIMENTAL

PPV\<14% before anesthesia induction, HES 6ml/kg infused

Drug: Volume loading; Other: PPV<14%

P(-)V(-)

EXPERIMENTAL

PPV\<14% before anesthesia induction, no additional volume infused

Other: PPV<14%

Interventions

PPV<14% OTHER

Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14

P(-)V(+); P(-)V(-)

Volume loading DRUG

Hydroxyethyl starch solution 6ml/kg iv injection

P(+)V(+); P(-)V(+)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jae-Hyon Bahk

CONTACT

82-2-2072-2818; bahkjh@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: August 5, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (1)