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

NCT ID: NCT02208570

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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P(+)V(+)

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

Group Type EXPERIMENTAL

PPV>14%

Intervention Type OTHER

Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14

Volume loading

Intervention Type DRUG

Hydroxyethyl starch solution 6ml/kg iv injection

P(+)V(-)

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

Group Type EXPERIMENTAL

PPV>14%

Intervention Type OTHER

Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14

P(-)V(+)

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

Group Type EXPERIMENTAL

Volume loading

Intervention Type DRUG

Hydroxyethyl starch solution 6ml/kg iv injection

PPV<14%

Intervention Type OTHER

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

P(-)V(-)

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

Group Type EXPERIMENTAL

PPV<14%

Intervention Type OTHER

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

Interventions

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PPV>14%

Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14

Intervention Type OTHER

Volume loading

Hydroxyethyl starch solution 6ml/kg iv injection

Intervention Type DRUG

PPV<14%

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Hyon Bahk, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae-Hyon Bahk

Role: CONTACT

82-2-2072-2818

Facility Contacts

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Jae-Hyon Bahk

Role: primary

82-2-2072-0641

Other Identifiers

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JHBahk_PPV_predictability

Identifier Type: -

Identifier Source: org_study_id

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