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

NCT03467711 | Completed

• 1 other identifier: 2017-009-003-002
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• PPV8

  augmented pulse pressure variation using a temporary increase in VT

  3min after tidal volume challenge

• SVV8

  augmented stroke volume variation using a temporary increase in VT

  3min after tidal volume challenge

Secondary Outcomes (6)

• ΔPPV6-8

  3min after tidal volume challenge

• ΔSVV6-8

  3min after tidal volume challenge

• PPV6

  Before fluid expansion

• SVV6

  Before fluid expansion

• PPV_fb

  5min after fluid expansion

Interventions

tidal volume challenge OTHER

transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)

volume expansion OTHER

give 6ml/kg (predicted body weight) volulyte for 10min

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

tertiary care center

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

• Jun JH, Chung RK, Baik HJ, Chung MH, Hyeon JS, Lee YG, Park SH. The tidal volume challenge improves the reliability of dynamic preload indices during robot-assisted laparoscopic surgery in the Trendelenburg position with lung-protective ventilation. BMC Anesthesiol. 2019 Aug 7;19(1):142. doi: 10.1186/s12871-019-0807-6.

  PMID: 31390982 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 16, 2018
• Study Start: March 16, 2018
• Primary Completion: March 16, 2018
• Study Completion: May 1, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

KR (1)