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

Primary Purpose

Hypotension

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PPV>14%

Volume loading

PPV<14%

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Hypotension during anesthesia induction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

P(+)V(+)

P(+)V(-)

P(-)V(+)

P(-)V(-)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02208570

First Posted

July 14, 2014

Last Updated

April 19, 2016

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02208570

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension

Keywords

Hypotension during anesthesia induction

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

P(+)V(+)

Arm Type

Experimental

Arm Description

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

Arm Title

P(+)V(-)

Arm Type

Experimental

Arm Description

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

Arm Title

P(-)V(+)

Arm Type

Experimental

Arm Description

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

Arm Title

P(-)V(-)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

PPV>14%

Intervention Description

Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14

Intervention Type

Drug

Intervention Name(s)

Volume loading

Intervention Description

Hydroxyethyl starch solution 6ml/kg iv injection

Intervention Type

Other

Intervention Name(s)

PPV<14%

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation

Description

Time Frame

Three minutes after anesthesia agent injection

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Three minutes before endotracheal intubation

Title

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

Description

Time Frame

Three minutes after endotracheal intubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jae-Hyon Bahk

Phone

82-2-2072-2818

bahkjh@snu.ac.kr

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jae-Hyon Bahk

Phone

82-2-2072-0641

bahkjh@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jae-Hyon Bahk

12. IPD Sharing Statement

Learn more about this trial

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

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