NCT05120258

Brief Summary

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4). One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7). In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2022

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 2, 2021

Last Update Submit

November 12, 2021

Conditions

Keywords

post spinal hypotension, the subclavian vein or infraclavicular axillary vein collapsibility index

Outcome Measures

Primary Outcomes (1)

  • Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension

    Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. This incidence is higher in pregnant women with a rate of 70%. Measurement of the IVC diameter and its collapsibility index before spinal anaesthesia has been shown to be a good predictive value of the occurrence of PSH. A previous study showed an acceptable correlation between the collapsibility of SCV (SCV-CI) and collapsibility of IVC (IVC-CI) in surgical and intensive care patients. In this study, we measured the preoperative collapsibility index of the SCV or the infraclavicular axillary vein during respiratory variation, and then examined whether these parameters could predict hypotension after spinal anaesthesia in patients undergoing ceserean

    45 min

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

ASA I-II physical status patients scheduled for cesarean section under spinal anesthesia

You may qualify if:

  • Spinal anesthesia
  • ceserean operation
  • American Society of Anesthesiologists' (ASA) physical status I-II

You may not qualify if:

  • Patients who underwent cesarean section in emergency conditions
  • Patients who underwent cesarean section under general anesthesia
  • American Society of Anesthesiologists' (ASA) physical status III-IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Emine ASLANLAR, assis. prof.

    selcuk univercity medical faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine ASLANLAR, assis. prof.

CONTACT

Mehmet SARGIN, assoc. prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

November 8, 2021

Primary Completion

January 24, 2022

Study Completion

March 2, 2022

Last Updated

November 15, 2021

Record last verified: 2021-11