The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery

February 19, 2019 updated by: Jun joohyun, Hallym University Kangnam Sacred Heart Hospital

The Use of Tidal Volume Challenge to Improve the Reliability of Dynamic Parameters (Pulse Pressure Variation and Stroke Volume Variation) During Pneumoperitoneum and Laparoscopic Surgery

Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Many studies have reported that less invasive dynamic indices such as pulse pressure variation (PPV) and stroke volume variation (SVV), which are derived from the arterial pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system.

Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned.

It has been clearly shown that the values of dynamic parameters are significantly correlated with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%, respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg, augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with high sensitivity and specificity, even in critically ill patients receiving low VT.

Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8 ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also assessed the ability of absolute changes in PPV and SVV values induced by a temporary increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

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

Study Locations

      • Seoul, Korea, Republic of
        • Kangnam Sacred Heart Hospital, Hallym University College of Medicine

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

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

tertiary care center

Description

Inclusion Criteria:

  • Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position

Exclusion Criteria:

  • preoperative arrhythmia
  • Severe bradycardia
  • Moderate to severe valvular disease
  • left ventricular ejection fraction < 50%
  • Poorly controlled hypertension (systolic BP > 160 mmHg)
  • Patients with renal insufficiency (creatinine > 1.5 mg/dL)
  • Moderate to severe liver disease
  • BMI >.30 or < 15 kg/ m2
  • preexisting pulmonary disease
  • FEV1 < 60% of predicted value
  • contraindications to oesophageal Doppler (OED) monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV8
Time Frame: 3min after tidal volume challenge
augmented pulse pressure variation using a temporary increase in VT
3min after tidal volume challenge
SVV8
Time Frame: 3min after tidal volume challenge
augmented stroke volume variation using a temporary increase in VT
3min after tidal volume challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ΔPPV6-8
Time Frame: 3min after tidal volume challenge
The changes in pulse pressure variation obtained by transiently increasing tidal volume
3min after tidal volume challenge
ΔSVV6-8
Time Frame: 3min after tidal volume challenge
The changes in stroke volume variation obtained by transiently increasing tidal volume
3min after tidal volume challenge
PPV6
Time Frame: Before fluid expansion
The value of pulse pressure variation when protective ventilation applied
Before fluid expansion
SVV6
Time Frame: Before fluid expansion
The value of stroke volume variation when protective ventilation applied
Before fluid expansion
PPV_fb
Time Frame: 5min after fluid expansion
The change in PPV after giving the fluid expansion
5min after fluid expansion
SVV_fb
Time Frame: 5min after fluid expansion
The change in SVV after giving the fluid bolus
5min after fluid expansion

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

March 16, 2018

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

March 10, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-009-003-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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