Laparoscopic SurgeryNCT03467711
The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery
An observational study of Laparoscopic Surgery, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- tidal volume challenge and volume expansion
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2018to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: tertiary care center
Who may be able to join
- Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Seoul
About this study
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
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.
Read more
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
- Being tested
- tidal volume challenge, volume expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tidal volume challengeOther
transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)
volume expansionOther
give 6ml/kg (predicted body weight) volulyte for 10min
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV8
augmented pulse pressure variation using a temporary increase in VT
Measured: 3min after tidal volume challenge
SVV8
augmented stroke volume variation using a temporary increase in VT
Measured: 3min after tidal volume challenge
Secondary outcomes (6)
ΔPPV6-8
The changes in pulse pressure variation obtained by transiently increasing tidal volume
Measured: 3min after tidal volume challenge
ΔSVV6-8
The changes in stroke volume variation obtained by transiently increasing tidal volume
Measured: 3min after tidal volume challenge
PPV6
The value of pulse pressure variation when protective ventilation applied
Measured: Before fluid expansion
SVV6
The value of stroke volume variation when protective ventilation applied
Measured: Before fluid expansion
PPV_fb
The change in PPV after giving the fluid expansion
Measured: 5min after fluid expansion
SVV_fb
The change in SVV after giving the fluid bolus
Measured: 5min after fluid expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start16 Mar 2018
- Primary completion16 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun joohyun, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467711
- Sponsor's protocol ID
- 2017-009-003-002
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31390982
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03467711
- Acronym / sponsor ID
- 2017-009-003-002
- Conditions
- Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care center
Key inclusion criteria (1 listed)
- Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position
Key exclusion criteria (11 listed)
- preoperative arrhythmia
- Severe bradycardia
- Moderate to severe valvular disease
- left ventricular ejection fraction < 50%
- Poorly controlled hypertension (systolic BP > 160 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tidal volume challengetransiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge) | Other | – |
| volume expansiongive 6ml/kg (predicted body weight) volulyte for 10min | Other | – |
Primary outcome
PPV8
Time frame: 3min after tidal volume challenge
augmented pulse pressure variation using a temporary increase in VT
SVV8
Time frame: 3min after tidal volume challenge
augmented stroke volume variation using a temporary increase in VT
6 secondary outcomes
ΔPPV6-8
Time frame: 3min after tidal volume challenge
ΔSVV6-8
Time frame: 3min after tidal volume challenge
PPV6
Time frame: Before fluid expansion
SVV6
Time frame: Before fluid expansion
PPV_fb
Time frame: 5min after fluid expansion
SVV_fb
Time frame: 5min after fluid expansion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 31390982Jun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPV8 (time frame: 3min after tidal volume challenge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.