NCT06633510

Brief Summary

Investigating the ideal fluid management in Trendelenburg positions during lower abdominal laparoscopic surgeries in gynecological oncology and surgical oncology patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

September 2, 2024

Last Update Submit

May 8, 2025

Conditions

Fluid Overload Without Edema

Outcome Measures

Primary Outcomes (16)

  • PI (perfusion index)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes results before induction

  • PVI (pleth variability index)

    arterial hemoglobin functional oxygen saturation % (SpO2, pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes results before induction

  • SPO2 (hemoglobin functional oxygen saturation)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes results before induction

  • PR (pulse rate beats per minute)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes results before induction

  • PI (perfusion index)

    arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes when c02 insufflation is performed into the abdomen

  • PVI (pleth variability index)

    arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes when c02 insufflation is performed into the abdomen

  • SPO2 (hemoglobin functional oxygen saturation)

    arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    ten minutes when c02 insufflation is performed into the abdomen

  • PR (pulse rate beats per minute)

    arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    t2(ten minutes when c02 insufflation is performed into the abdomen

  • PI (perfusion index)

    arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    two hours during the surgery in the trendelenburg position

  • PVI (pleth variability index)

    arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    two hours during the surgery in the trendelenburg position

  • SPO2 (hemoglobin functional oxygen saturation)

    arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    two hours during the surgery in the trendelenburg position

  • PR (pulse rate beats per minute)

    arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    two hours during the surgery in the trendelenburg position

  • PI (perfusion index)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    five minute send of surgery

  • PVI (pleth variability index)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    five minute send of surgery

  • SPO2 (hemoglobin functional oxygen saturation)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    five minute send of surgery

  • PR (pulse rate beats per minute)

    arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values

    five minute send of surgery

Study Arms (2)

Massimo group

ACTIVE COMPARATOR

The patient is not given fluids until the Massimo PVI score is \>25, a 300 cc fluid bolus is given when the PVI is above 25, and fluid loading is performed at an average rate until the PVI falls below 25. If the patient's Massimo PVI is below 25, restrictive fluid therapy is applied.

Device: massimo group

standart group

ACTIVE COMPARATOR

intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

Other: standart group

Interventions

massimo groupDEVICE

masimo is a device for the continuous noninvasive measurement of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index).

Massimo group
standart groupOTHER

intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.

standart group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • ASA score IV
  • Patients with heart failure and chronic kidney disease
  • Patients who did not agree to participate in the study
  • Cases that started laparoscopically and converted to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (4)

  • Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

    PMID: 20705785RESULT

  • Ghoundiwal D, Delaporte A, Bidgoli J, Forget P, Fils JF, Van der Linden P. Effect of pneumoperitoneum on dynamic variables of fluid responsiveness (Delta PP and PVI) during Trendelenburg position. Saudi J Anaesth. 2020 Jul-Sep;14(3):323-328. doi: 10.4103/sja.SJA_737_19. Epub 2020 May 30.

    PMID: 32934624RESULT

  • Agerskov M, Thusholdt ANW, Holm-Sorensen H, Wiberg S, Meyhoff CS, Hojlund J, Secher NH, Foss NB. Association of the intraoperative peripheral perfusion index with postoperative morbidity and mortality in acute surgical patients: a retrospective observational multicentre cohort study. Br J Anaesth. 2021 Sep;127(3):396-404. doi: 10.1016/j.bja.2021.06.004. Epub 2021 Jul 3.

    PMID: 34226038RESULT

  • Yildiz GO, Hergunsel GO, Sertcakacilar G, Akyol D, Karakas S, Cukurova Z. Perioperative goal-directed fluid management using noninvasive hemodynamic monitoring in gynecologic oncology. Braz J Anesthesiol. 2022 May-Jun;72(3):322-330. doi: 10.1016/j.bjane.2021.12.012. Epub 2022 Feb 1.

    PMID: 35121063RESULT

Study Officials

  • ELA ERDEM HIDIROGLU

    ANKARA ETLİK CİTY HOSPİTAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 2, 2024

First Posted

October 9, 2024

Study Start

October 15, 2024

Primary Completion

April 18, 2025

Study Completion

May 5, 2025

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)