Trial Outcomes & Findings for Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ? (NCT NCT02360085)

Results Overview

Difference between total power (ms2) of patients in the hypotension group compared to stable group

Recruitment status

COMPLETED

Target enrollment

65 participants

Primary outcome timeframe

1 day

Results posted on

2022-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Cervical Myelopathy Undergoing Spine Surgery This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018.
Overall Study STARTED	65
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

49 patients were included for final analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Myelopathy Undergoing Spine Surgery n=49 Participants This is a prospective, single-center, observational study in adult (aged 18-70 years) patients undergoing elective anterior or posterior cervical decompression and fusion for cervical myelopathy in our institution during the period from Sept 2017 to June 2018.
Age, Customized Female	55 years STANDARD_DEVIATION 10.2 • n=49 Participants
Sex: Female, Male Female	14 Participants n=49 Participants • 49 patients were included for final analysis.
Sex: Female, Male Male	35 Participants n=49 Participants • 49 patients were included for final analysis.
Region of Enrollment Canada	49 participants n=49 Participants
Cervical myelopathy mild	37 Participants n=49 Participants
Cervical myelopathy moderate to severe	12 Participants n=49 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All data are presented as Median \[Interquartile range\]

Difference between total power (ms2) of patients in the hypotension group compared to stable group

Outcome measures

Outcome measures
Measure	Hypotension Group n=37 Participants HRV analysis in hypotension group	No Hypotension Group n=12 Participants HRV analysis in stable group
Heart Rate Variability (HRV)	1439 ms2 Interval 637.9 to 3130.5	2191 ms2 Interval 1229.5 to 2613.0

PRIMARY outcome

Timeframe: 1 day

Population: All data are presented as Median \[Interquartile range\]. VLF- very low frequency, LF-low frequency, HF- high frequency.

Differences in HRV indices between hypotension group and no hypotension group

Outcome measures

Outcome measures
Measure	Hypotension Group n=37 Participants HRV analysis in hypotension group	No Hypotension Group n=12 Participants HRV analysis in stable group
HRV Indices VLF	684.8 ms2 Interval 411.8 to 1399.5	705.8 ms2 Interval 566.8 to 1649.0
HRV Indices LF	290.2 ms2 Interval 143.6 to 1208.0	406.5 ms2 Interval 236.3 to 934.7
HRV Indices HF	109.7 ms2 Interval 64.8 to 430.8	350.4 ms2 Interval 185.7 to 1634.5

PRIMARY outcome

Timeframe: one day

Population: All data are presented as Median \[Interquartile range\]

Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group

Outcome measures

Outcome measures
Measure	Hypotension Group n=37 Participants HRV analysis in hypotension group	No Hypotension Group n=12 Participants HRV analysis in stable group
Mean Arterial Pressure	96.0 mmHg Interval 89.8 to 102.3	104.3 mmHg Interval 93.2 to 111.4

PRIMARY outcome

Timeframe: One day

Population: Low Frequency to High Frequency ratio. All data are presented as Median \[Interquartile range\].

Low frequency (LF)/High frequency Ratio

Outcome measures

Outcome measures
Measure	Hypotension Group n=37 Participants HRV analysis in hypotension group	No Hypotension Group n=12 Participants HRV analysis in stable group
HRV Indices Analysis	3.33 Ratio Interval 1.93 to 4.95	1.22 Ratio Interval 0.22 to 1.86

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emad Al Azazi

Toronto Western Hospital/UHN

Phone: 416-603-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place