NCT02556658

Brief Summary

The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

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

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

January 21, 2015

Last Update Submit

November 15, 2020

Conditions

Hip Fracture Surgery

Keywords

Smartpilot ViewHip fracture surgeryDepth of anaesthesiaIntraoperative hypotensionQuality of anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Percentage of time spent in the "appropriate anaesthesia zone"

    The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg

    participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery

Secondary Outcomes (9)

  • Dose of propofol

    participants will be followed for the duration anesthesia, an expected average of 5 hours

  • Dose of sufentanil

    participants will be followed for the duration anesthesia, an expected average of 5 hours

  • Time to extubation

    end of anaesthesia

  • "NASA Task Load Index"

    participants will be followed for the duration anesthesia, an expected average of 5 hours

  • Morphine consumption

    participants will be followed for the duration in recovery room, an expected average of 24 hours

  • +4 more secondary outcomes

Study Arms (2)

Smartpilot View group

EXPERIMENTAL

General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.

Device: General anesthesia managed by the Smartpilot® View

Control group

ACTIVE COMPARATOR

General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.

Device: General anesthesia managed without the Smartpilot® View

Interventions

General anesthesia managed by the Smartpilot® ViewDEVICE

General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.

Smartpilot View group
General anesthesia managed without the Smartpilot® ViewDEVICE

General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.

Control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing hip fracture surgery under general anaesthesia
  • Age ≥ 18 years old
  • ASA classification 1, 2 or 3

You may not qualify if:

  • Patient not insured by a social security scheme
  • Adult patient under tutorship or curatorship
  • Age over 18 years old or under 90 years old
  • Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm
  • Body mass index \> 35
  • Contraindication to one or more anaesthetics used in the study
  • Pregnancy or breastfeeding
  • Unweaned alcoholism
  • ASA classification 4 or 5
  • Patient undergoing hip fracture surgery under spinal anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Angers

Angers, 49933, France

Location

Related Publications (1)

  • Leblanc D, Conte M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chretien JM, Rony L, Rineau E, Lasocki S. SmartPilot(R) view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317.

    PMID: 29028921RESULT

Study Officials

  • Mathieu CONTE, M.D.

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

September 22, 2015

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

FR(1)