Hip Fracture SurgeryPhase 4NAPfemNCT02556658
Predicted Level of General Anaesthesia in Hip Fracture Surgery
A Phase 4 study testing General anesthesia managed by the Smartpilot® View and General anesthesia managed without the Smartpilot® View in people with Hip Fracture Surgery, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Fracture Surgery
- What is being tested?
- General anesthesia managed by the Smartpilot® View and General anesthesia managed without the Smartpilot® View
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing hip fracture surgery under general anaesthesia
- Age ≥ 18 years old
- ASA classification 1, 2 or 3
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy or breastfeeding
- Unweaned alcoholism
- ASA classification 4 or 5
- Patient undergoing hip fracture surgery under spinal anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hip Fracture Surgery
- Being tested
- General anesthesia managed by the Smartpilot® View, General anesthesia managed without the Smartpilot® View
- Keywords
- Smartpilot View, Hip fracture surgery, Depth of anaesthesia, Intraoperative hypotension, Quality of anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: General anesthesia managed without the Smartpilot® View |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: participants will be followed for the duration anesthesia, an expected average of 5 hours
Dose of sufentanil
Measured: participants will be followed for the duration anesthesia, an expected average of 5 hours
Time to extubation
Measured: end of anaesthesia
"NASA Task Load Index"
Measured: participants will be followed for the duration anesthesia, an expected average of 5 hours
Morphine consumption
Measured: participants will be followed for the duration in recovery room, an expected average of 24 hours
Incidence of awareness with recall during anaesthesia
Measured: postoperative day 1
"Postoperative Quality Recovery Scale"
Measured: during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Length of stay
Measured: postoperative day 30
Mortality
Measured: postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Fracture SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mathieu CONTE, M.D., Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556658
- Sponsor's protocol ID
- 2014-A01243-44
- Acronym
- NAPfem
- Status last verified
- Nov 2020
- First submitted
- 21 Jan 2015
- Last updated
- 17 Nov 2020
- Results posted
- No
Publications
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.
PubMed 29028921
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicted Level of General Anaesthesia in Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT02556658
- Acronym / sponsor ID
- NAPfem / 2014-A01243-44
- Conditions
- Hip Fracture Surgery
- Keywords
- Smartpilot View, Hip fracture surgery, Depth of anaesthesia, Intraoperative hypotension, Quality of anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartpilot View group | Experimental | Device: General anesthesia managed by the Smartpilot® ViewGeneral 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. |
| Control group | Active comparator | Device: General anesthesia managed without the Smartpilot® ViewGeneral 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing hip fracture surgery under general anaesthesia
- Age ≥ 18 years old
- ASA classification 1, 2 or 3
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesia managed by the Smartpilot® ViewGeneral 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 | Smartpilot View group |
| General anesthesia managed without the Smartpilot® ViewGeneral 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 | Control group |
Primary outcome
Percentage of time spent in the "appropriate anaesthesia zone"
Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery
The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg
9 secondary outcomes
Dose of propofol
Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours
Dose of sufentanil
Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours
Time to extubation
Time frame: end of anaesthesia
"NASA Task Load Index"
Time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours
Morphine consumption
Time frame: participants will be followed for the duration in recovery room, an expected average of 24 hours
Incidence of awareness with recall during anaesthesia
Time frame: postoperative day 1
"Postoperative Quality Recovery Scale"
Time frame: during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Length of stay
Time frame: postoperative day 30
Mortality
Time frame: postoperative day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Results publication: PubMed 29028921Leblanc 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.
Related trials for Hip Fracture Surgery
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu CONTE, M.D. principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing General anesthesia managed by the Smartpilot® View and General anesthesia managed without the Smartpilot® View in people with Hip Fracture Surgery, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in the "appropriate anaesthesia zone" (time frame: participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.