CClinicalTrials.gg
Status unknownNCT03267017Updated Aug 30, 2017

Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability

An observational study in Heart Rate Determination, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Rambam Health Care Campus · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
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Study summary

This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus

02

Conditions studied

  • Heart Rate Determination

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Study patients

Inclusion criteria

  • Age 18-80
  • Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring

Exclusion criteria

Exclusion Criteria:

  • Heart Rate other than sinus
  • Cardiac Pacemaker Status
  • Transplanted Heart
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient scheduled for surgery under general anesthesia

    Other: posture changes

Interventions

  • Otherposture changes

    Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O

05

What researchers measure

Primary outcomes

  1. Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure

    Time frame: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03267017
Lead sponsor
Rambam Health Care Campus
Responsible party
Dr. Amit Lehavi MD FANZCA (Director of Pediatric Anesthesia, Rambam Health Care Campus) — Principal investigator
First posted
Aug 30, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Nov 1, 2018 (estimated)
Completion
May 1, 2019 (estimated)
Last update
Aug 30, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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