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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467711
• Other study ID #: 2017-009-003-002
• Status: Completed
• Start date: March 16, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: February 2019
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 1, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Other:
• tidal volume challenge
transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)
• volume expansion
give 6ml/kg (predicted body weight) volulyte for 10min

Locations

Country	Name	City	State
Korea, Republic of	Kangnam Sacred Heart Hospital, Hallym University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPV8	augmented pulse pressure variation using a temporary increase in VT	3min after tidal volume challenge
Primary	SVV8	augmented stroke volume variation using a temporary increase in VT	3min after tidal volume challenge
Secondary	?PPV6-8	The changes in pulse pressure variation obtained by transiently increasing tidal volume	3min after tidal volume challenge
Secondary	?SVV6-8	The changes in stroke volume variation obtained by transiently increasing tidal volume	3min after tidal volume challenge
Secondary	PPV6	The value of pulse pressure variation when protective ventilation applied	Before fluid expansion
Secondary	SVV6	The value of stroke volume variation when protective ventilation applied	Before fluid expansion
Secondary	PPV_fb	The change in PPV after giving the fluid expansion	5min after fluid expansion
Secondary	SVV_fb	The change in SVV after giving the fluid bolus	5min after fluid expansion