Deflation Induced HypotensionNCT03967119
Assessments of Dynamic Variables of Fluid Responsiveness to Predict Desufflation-induced Hypotension in Urologic Patients Undergoing Laparoscopic Surgery
An observational study of Deflation Induced Hypotension and Laparoscopic Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Laparoscopic surgery can induce hemodynamic pertubations. Pneumoperitoneum, inevitable in laparoscopic surgery, induces increase in intra-abdominal pressure, which can decrease cardiac output. Simultaneously, pneumoperitoneum can stimulate sympathetic system and increase vascular resistance/arterial blood pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Deflation Induced Hypotension, Laparoscopic Surgery
- What is being tested?
- Patient monitoring
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2019to Apr 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing laparoscopic surgery for urologic procedures
Who may be able to join
- 1. laparoscopic nephrectomy
- 2. laparoscopic nephro-ureterectomy
- 3. laparoscopic adrenalectomy
Who cannot join
- 1. ASA physical status 3 and greater
- 2. preoperative arrhythmia
- 3. moderate to severe valvular disease
- 4. ventricular ejection fraction < 40%
- 5. inotrope use
- 6. moderate to severe chronic obstructive pulmonary disease
- 7. moderate to severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
Seoul, 120-752
Jae Hoon Lee, MD, 82 2 2228 2420, neogens@yuhs.ac
About this study
Laparoscopic surgery can induce hemodynamic pertubations. Pneumoperitoneum, inevitable in laparoscopic surgery, induces increase in intra-abdominal pressure, which can decrease cardiac output. Simultaneously, pneumoperitoneum can stimulate sympathetic system and increase vascular resistance/arterial blood pressure. Patients undergoing laparoscopic surgery may show a normal range of blood pressure during pneumoperitoneum even when the patients are in hypovolemia, and desufflation at the end of main surgical procedure can cause an abrupt hypotension revealing hypovolemia. Therefore, appropriate fluid management is essential for preventing desufflation-induced hypotension in laparoscopic surgery. Recently, dynamic variables are used to predict and guide fluid therapy during controlled ventilation. these variables arise from heart-lung interactions during positive ventilation, which influence left ventricular stroke volume. Several dynamic variables are derived from variations in left ventricular stroke volume (stroke volume variation, SVV), for example pulse pressure variation (PPV), and variations in pulse oximetry plethysmography waveform amplitude (PWV), which have all been shown to predict fluid responsiveness in different clinical and experimental settings. However, there are few evidences regarding which type of dynamic variables can predict desufflation-induced hypotension in laparoscopic surgery. Therefore, this study was designed to assess the predictive abilities of three different type of dynamic variables including PPV, SVV, and PWV for desufflation-induced hypotension in patients undergoing laparoscopic surgery.
Read the detailed description
The study is a prospective, single-arm, and observational one. Eighty Patients who age more than 19 years and are undergoing laparoscopic surgery for urologic procedures are being enrolled in this study. All anesthetic and surgical managements are being performed according to the institutional standards. An attending anesthesiologist who is independent from this study performs anesthetic managements for the participants including fluid administration.
Investigators assess and record the following parameters at the following time points.
The parameters assessed: mean arterial pressure, heart rate, pulse oxygen saturation, SVV, PPV, PWV, peak inspiratory pressure, plateau pressure, positive end-expiratory pressure, respiratory rate (all dynamic variables are assessed at two levels of tidal volume- 6 ml/kg and 12 ml/kg).
The time points: T0, before anesthetic induction; T1, immediately after anesthetic induction; T2, immediately after pneumoperitoneum; T3, 10 min before desufflation; T4, immediately after desufflation.
The desufflation-induced hypotension is defined as more than 20 % decrease in MAP at T4 from MAP at T3.
- Being tested
- Patient monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient monitoringDevice
Arterial blood pressure, pulse oxygen saturation, and cardiac output/stroke volume are monitored with invasive arterial catheter, pulse oxymetry, and esophageal doppler in all participants. Some dynamic variables including SVV and PPV are automatically calculated in each monitor. PWV is manually calculated in a printed plethysmographic waveform. Plethysmographic waveform amplitude (PW) is measured on a beat-to-beat basis as the vertical distance between peaks and preceding valley troughs in the waveform. The maximum PW (PWmax) and minimum PW (PWmin) are determined manually over the same respiratory cycle, and PWV is calculated. PWV=(PWmax-PWmin)/[(PWmax+PWmin)/2].
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | The following parameters are assessed and recorded at the following time points in all participants.
The parameters assessed: mean arterial pressure, heart rate, pulse oxygen saturation, SVV, PPV, PWV, peak inspiratory pressure, plateau pressure, positive end-expiratory pressure, respiratory rate (all dynamic variables are assessed at two levels of tidal volume- 6 ml/kg and 12 ml/kg).
The time points: T0, before anesthetic induction; T1, immediately after anesthetic induction; T2, immediately after pneumoperitoneum; T3, 10 min before desufflation; T4, immediately after desufflation.
The desufflation-induced hypotension is defined as more than 20 % decrease in MAP at T4 from MAP at T3. Receives: Device: Patient monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for dynamic variables to predict deflation-induced hypotension
To test the abilities of dynamic variables to predict curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
Measured: Dynamic variables at T3 (10 minutes before desufflation)
AUC for dynamic variables to predict deflation-induced hypotension
To test the abilities of dynamic variables to predict desufflation-induced hypotension, the areas under receiver-operating characteristic curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
Measured: Hypotension occurence at T4 (immediately after desufflation)
Secondary outcomes (2)
Cut-off value for dynamic variables to predict deflation-induced hypotension
To apply dynamic variables to predict desufflation-induced hypotension into clinical practice, the cut-off values are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
Measured: Dynamic variables at T3 (10 minutes before desufflation)
Cut-off value for dynamic variables to predict deflation-induced hypotension
To apply dynamic variables to predict desufflation-induced hypotension into clinical practice, the cut-off values are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
Measured: Hypotension occurence at T4 (immediately after desufflation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start25 Apr 2019
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deflation Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967119
- Sponsor's protocol ID
- 4-2019-0203
- Status last verified
- Aug 2021
- First submitted
- 26 May 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments of Dynamic Variables of Fluid Responsiveness to Predict Desufflation-induced Hypotension in Urologic Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03967119
- Acronym / sponsor ID
- 4-2019-0203
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 30 May 2019 (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.
Laparoscopic surgery can induce hemodynamic pertubations. Pneumoperitoneum, inevitable in laparoscopic surgery, induces increase in intra-abdominal pressure, which can decrease cardiac output. Simultaneously, pneumoperitoneum can stimulate sympathetic system and increase vascular resistance/arterial blood pressure. Patients undergoing laparoscopic surgery may show a normal range of blood pressure during pneumoperitoneum even when the patients are in hypovolemia, and desufflation at the end of main surgical procedure can cause an abrupt hypotension revealing hypovolemia. Therefore, appropriate fluid management is essential for preventing desufflation-induced hypotension in laparoscopic surgery. Recently, dynamic variables are used to predict and guide fluid therapy during controlled ventilation. these variables arise from heart-lung interactions during positive ventilation, which influence left ventricular stroke volume. Several dynamic variables are derived from variations in left ventricular stroke volume (stroke volume variation, SVV), for example pulse pressure variation (PPV), and variations in pulse oximetry plethysmography waveform amplitude (PWV), which have all been shown to predict fluid responsiveness in different clinical and experimental settings. However, there are few evidences regarding which type of dynamic variables can predict desufflation-induced hypotension in laparoscopic surgery. Therefore, this study was designed to assess the predictive abilities of three different type of dynamic variables including PPV, SVV, and PWV for desufflation-induced hypotension in patients undergoing laparoscopic surgery.
Detailed description
The study is a prospective, single-arm, and observational one. Eighty Patients who age more than 19 years and are undergoing laparoscopic surgery for urologic procedures are being enrolled in this study. All anesthetic and surgical managements are being performed according to the institutional standards. An attending anesthesiologist who is independent from this study performs anesthetic managements for the participants including fluid administration.
Investigators assess and record the following parameters at the following time points.
The parameters assessed: mean arterial pressure, heart rate, pulse oxygen saturation, SVV, PPV, PWV, peak inspiratory pressure, plateau pressure, positive end-expiratory pressure, respiratory rate (all dynamic variables are assessed at two levels of tidal volume- 6 ml/kg and 12 ml/kg).
The time points: T0, before anesthetic induction; T1, immediately after anesthetic induction; T2, immediately after pneumoperitoneum; T3, 10 min before desufflation; T4, immediately after desufflation.
The desufflation-induced hypotension is defined as more than 20 % decrease in MAP at T4 from MAP at T3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | – | Device: Patient monitoringThe following parameters are assessed and recorded at the following time points in all participants. The parameters assessed: mean arterial pressure, heart rate, pulse oxygen saturation, SVV, PPV, PWV, peak inspiratory pressure, plateau pressure, positive end-expiratory pressure, respiratory rate (all dynamic variables are assessed at two levels of tidal volume- 6 ml/kg and 12 ml/kg). The time points: T0, before anesthetic induction; T1, immediately after anesthetic induction; T2, immediately after pneumoperitoneum; T3, 10 min before desufflation; T4, immediately after desufflation. The desufflation-induced hypotension is defined as more than 20 % decrease in MAP at T4 from MAP at T3. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic surgery for urologic procedures
Key inclusion criteria (3 listed)
- 1. laparoscopic nephrectomy
- 2. laparoscopic nephro-ureterectomy
- 3. laparoscopic adrenalectomy
Key exclusion criteria (7 listed)
- 1. ASA physical status 3 and greater
- 2. preoperative arrhythmia
- 3. moderate to severe valvular disease
- 4. ventricular ejection fraction < 40%
- 5. inotrope use
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 |
|---|---|---|
| Patient monitoringArterial blood pressure, pulse oxygen saturation, and cardiac output/stroke volume are monitored with invasive arterial catheter, pulse oxymetry, and esophageal doppler in all participants. Some dynamic variables including SVV and PPV are automatically calculated in each monitor. PWV is manually calculated in a printed plethysmographic waveform. Plethysmographic waveform amplitude (PW) is measured on a beat-to-beat basis as the vertical distance between peaks and preceding valley troughs in the waveform. The maximum PW (PWmax) and minimum PW (PWmin) are determined manually over the same respiratory cycle, and PWV is calculated. PWV=(PWmax-PWmin)/[(PWmax+PWmin)/2]. | Device | Laparoscopic surgery |
Primary outcome
AUC for dynamic variables to predict deflation-induced hypotension
Time frame: Dynamic variables at T3 (10 minutes before desufflation)
To test the abilities of dynamic variables to predict curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
AUC for dynamic variables to predict deflation-induced hypotension
Time frame: Hypotension occurence at T4 (immediately after desufflation)
To test the abilities of dynamic variables to predict desufflation-induced hypotension, the areas under receiver-operating characteristic curves (AUC) are calculated in each type of dynamic variables at each tidal volume level (6 or 12 ml/kg).
2 secondary outcomes
Cut-off value for dynamic variables to predict deflation-induced hypotension
Time frame: Dynamic variables at T3 (10 minutes before desufflation)
Cut-off value for dynamic variables to predict deflation-induced hypotension
Time frame: Hypotension occurence at T4 (immediately after desufflation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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.
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 Deflation Induced Hypotension and Laparoscopic Surgery, run by Yonsei University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaehoon Lee (+82-2-2228-2420, neogens@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC for dynamic variables to predict deflation-induced hypotension (time frame: Dynamic variables at T3 (10 minutes before desufflation)). 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?
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 12 Aug 2021.