Non Invasive Cardiac Output Monitoring to Guide Goal Directed Fluid Therapy in High Risk Patients Undergoing Urgent Surgical Repair of Proximal Femoral Fractures

NCT02382185 | Completed

• 1 other identifier: YOR-A02333
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Improving or maximising cardiac output in the perioperative setting through the use of goal directed fluid therapy has been shown to reduce complications and length of hospital stay in patients undergoing major abdominal surgery. The evidence for patients having surgery to repair a fractured neck of femur is less robust but many of these latter patients are elderly and often at high risk of complications. Patients undergoing surgery (including surgery for hip fracture) under spinal anaesthesia have not had access to goal directed fluid therapy because of the invasive nature of the existing monitoring technology such as oesophageal doppler. The availability of a non invasive cardiac monitoring device, the Clearsight™, now makes goal directed fluid therapy a possibility for this group of patients. This is a randomised controlled, observer blinded trial to assess the effects of goal directed fluid therapy in high-risk patients undergoing surgical repair of proximal femoral fractures. The aim of the trial is to test the hypothesis that maximising circulating volume intra-operatively with balanced crystalloid reduces post-operative morbidity in high-risk patients undergoing urgent surgical repair of proximal femoral fractures.

Conditions

Hip Fractures

Keywords

Cardiac output

Outcome Measures

Primary Outcomes (1)

• Composite basket of complication

  The number of patients who develop one or more in hospital post operative complications as defined by Copeland (POSSUM) and modified for this patient group

  In hospital participants are expected to have a median hospital length of stay of 18 days

Secondary Outcomes (11)

• Incidence of major and minor complications

  in hospital -Participants are expected to have a median hospital length of stay of 18 days

• Morbidity at day 3, 5, 10 measured by Post operative morbidity survey

  10 days

• Length of stay in hospital after surgery.

  In hospital- participants are expected to have a median hospital length of stay of 18 days

• time to drinking

  in hospital - participants are expected to have a median hospital length of stay of 18 days

• time to eating

  in hospital - participants are expected to have a median hospital length of stay of 18 days

Study Arms (2)

Usual care

EXPERIMENTAL

No intervention apart from application of clearsight monitor. Prior to induction of anaesthesia the control group will have a Clearsight cardiac monitor probe placed on a suitable finger and baseline haemodynamic measurements will be taken. All fluid management and administration of vasopressor therapy will be at the discretion of the anaesthetist as per the current practice at the host institution. Data on stroke volume, heart rate, blood pressure, cardiac output, oxygen saturations, will be recorded at baseline and then every 5 minutes.

Device: Application of clearsight monitor

Fluid optimisation

EXPERIMENTAL

Application of clearsight monitor, optimisation of blood pressure and fluid optimisation. A Clearsight cardiac probe is attached and after induction of anaesthesia stroke volume is optimised using 250ml boluses of Hartmann's solution. The SV measurement prior to the final fluid bolus will be the optimal SV. Mean arterial blood pressure will be maintained within 30% of baseline values using a phenylephrine infusion.Data on haemodynamics will be recorded at baseline and then every 5 minutes, as well as before and after a fluid bolus. Haemoglobin will be maintained at\>10g/dL with blood transfusion as required.

Other: Fluid optimisation; Drug: Optimisation of blood pressure; Device: Application of clearsight monitor

Interventions

Fluid optimisation OTHER

The intervention will consist of optimising stroke volume with 250ml of Hartmanns solution

Fluid optimisation

Optimisation of blood pressure DRUG

Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value

Fluid optimisation

Application of clearsight monitor DEVICE

The clear sight monitor will be applied to measure stroke volume.

Fluid optimisation; Usual care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients due to undergo urgent or emergency repair of a proximal femoral fracture who have a Nottingham hip fracture score (NHFS) ≥ 5 i.e. patients who are regarded as 'high risk'.

You may not qualify if:

• Age \< 50 years. Patients scoring 5 on the American Society of Anesthesiologists (ASA) physical status classification Multiple injuries requiring operative management

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (2)

York Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, YO318HE, United Kingdom

Location

Harrogate Hospital

Harrogate, Yorkshire, United Kingdom

Location

Related Publications (1)

• Davies SJ, Yates DR, Wilson RJT, Murphy Z, Gibson A, Allgar V, Collyer T. A randomised trial of non-invasive cardiac output monitoring to guide haemodynamic optimisation in high risk patients undergoing urgent surgical repair of proximal femoral fractures (ClearNOF trial NCT02382185). Perioper Med (Lond). 2019 Aug 8;8:8. doi: 10.1186/s13741-019-0119-x. eCollection 2019.

  PMID: 31406569 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Simon Davies, MB FRCA MD

  York Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: March 6, 2015
• Study Start: January 1, 2015
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

GB (2)