Trial Outcomes & Findings for Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery (NCT NCT02240368)

Results Overview

The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

Results posted on

2018-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Children age between 1 month to 12 months	Group 2 Children age between 13 months and 36 months	Group 3 Children age between 37 months to 144 months
Overall Study STARTED	9	22	19
Overall Study COMPLETED	8	22	18
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Children age between 1 month to 12 months	Group 2 Children age between 13 months and 36 months	Group 3 Children age between 37 months to 144 months
Overall Study Surgery lasted less then 20 minutes	1	0	0
Overall Study Entropy failed to detect more than 50%	0	0	1

Baseline Characteristics

Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=8 Participants Children age between 1 month to 12 months	Group 2 n=22 Participants Children age between 13 months and 36 months	Group 3 n=18 Participants Children age between 37 months to 144 months	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	48 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	6.63 months STANDARD_DEVIATION 3.7 • n=5 Participants	24.95 months STANDARD_DEVIATION 8.0 • n=7 Participants	82.22 months STANDARD_DEVIATION 33.8 • n=5 Participants	43.38 months STANDARD_DEVIATION 37.56 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Italy	8 participants n=5 Participants	22 participants n=7 Participants	18 participants n=5 Participants	48 participants n=4 Participants

PRIMARY outcome

Timeframe: BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Children age between 1 month to 12 months	Group 2 n=22 Participants Children age between 13 months and 36 months	Group 3 n=18 Participants Children age between 37 months to 144 months
BISPECTRAL Index	0.6 units on a scale Interval 0.57 to 0.61	0.66 units on a scale Interval 0.64 to 0.67	0.73 units on a scale Interval 0.71 to 0.74

PRIMARY outcome

Timeframe: Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours

The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group. Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Children age between 1 month to 12 months	Group 2 n=22 Participants Children age between 13 months and 36 months	Group 3 n=18 Participants Children age between 37 months to 144 months
Entropy	0.64 units on a scale Interval 0.62 to 0.65	0.66 units on a scale Interval 0.65 to 0.68	0.72 units on a scale Interval 0.71 to 0.74

SECONDARY outcome

Timeframe: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Children age between 1 month to 12 months	Group 2 n=22 Participants Children age between 13 months and 36 months	Group 3 n=18 Participants Children age between 37 months to 144 months
BISPECTRAL Index Awaking	75 units on a scale Interval 62.0 to 78.0	86 units on a scale Interval 77.0 to 92.0	81 units on a scale Interval 74.0 to 88.0

SECONDARY outcome

Timeframe: reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia

In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Children age between 1 month to 12 months	Group 2 n=22 Participants Children age between 13 months and 36 months	Group 3 n=18 Participants Children age between 37 months to 144 months
Entropy Awaking	63 units on a scale Interval 49.0 to 71.0	96 units on a scale Interval 93.0 to 98.0	86 units on a scale Interval 78.0 to 96.0

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

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

Alberto Sciusco

University of Foggia

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place