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

April 19, 2016 updated by: Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Hyon Bahk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: P(+)V(+)
PPV>14% before anesthesia induction, HES 6ml/kg infused
Other: PPV>14%
Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14
Drug: Volume loading
Hydroxyethyl starch solution 6ml/kg iv injection
EXPERIMENTAL: P(+)V(-)
PPV>14% before anesthesia induction, no additional volume infused
Other: PPV>14%
Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14
EXPERIMENTAL: P(-)V(+)
PPV<14% before anesthesia induction, HES 6ml/kg infused
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
EXPERIMENTAL: P(-)V(-)
PPV<14% before anesthesia induction, no additional volume infused
Other: PPV<14%
Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation
Time Frame: 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.
Three minutes after anesthesia agent injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation
Time Frame: 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.
Three minutes before endotracheal intubation
Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation
Time Frame: 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.
Three minutes after endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (ESTIMATE)

August 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHBahk_PPV_predictability

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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