COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Apgar Score in Clinical Practice: a Pilot Study (SAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799369
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
London Surgical Research Group

Brief Summary:

Background Surgeons lack a routine, objective evaluation of patient condition after surgery. We currently rely on subjective assessment of available patient data. The current scoring methods such as Acute Physiology and Chronic Health Evaluation and Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity are complex and cumbersome and have therefore not been adopted into routine practice.

The Surgical Apgar Score (SAS) is a simple score on a scale of 0 to 10 calculated from 3 parameters collected during the operation: lowest heart rate, lowest blood pressure, estimated blood loss (Regenbogen et al., Arch Surg 2009).

Previous validation studies have shown a good correlation between the score and incidence of major complications or death occurring within 30 days. For example, 75% patients with a score of 0-2 had major complications, whereas it was only 5% in those with a score of 9-10. To date, the SAS has never been clinically applied and tested in a trial.

We believe that routine use of the SAS will lead to a reduction in major complications and deaths after surgery. We also believe that it will lead to a reduction in the severity of the complications.

This is based on our theory that the SAS eliminates the guesswork. Using this score will add objectivity and clarity to clinical decisions that are presently based on clinical instinct or 'gut feeling'. The score will more clearly highlight those patients who are at an increased risk of developing complications or dying and will flag them up for increased monitoring, a higher index of clinical suspicion and a lower threshold for early management of problems.

Primary Aim The primary aim of the pilot is to strengthen the design and assess the feasibility of the main study on the SAS. We aim to recruit 100 patients in each group, 200 in total. The primary aim of the main study will be to establish if clinical application of the SAS leads to a reduction in 30-day post-operative morbidity and mortality.

Study Design The design of this pilot is the same as what the main trial will eventually be: a multicentre single-blind randomised controlled trial (RCT). Current data suggests the overall expected major complication or death rate in our target population would be 21%. The sample size of the future RCT is therefore estimated to be 986 each group to detect a 5% reduction in complications (Significance 0.05%, Power 80%).

Outcomes Our primary outcome will be major complications or death within 30 days of operation. Our secondary outcomes (all within 30 days of operation) will be minor complications, primary and secondary critical care admissions and length of stay, duration of therapeutic antibiotics, number of additional operations under general anaesthetic to treat complications, and overall length of stay.


Condition or disease Intervention/treatment Phase
Postoperative Care Behavioral: Surgical Apgar Score Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Surgical Apgar Score in Clinical Practice: a Pilot Study
Study Start Date : April 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
No Intervention: Control
Routine post-operative care
Experimental: Intervention
Post-operative care influenced by the Surgical Apgar Score
Behavioral: Surgical Apgar Score
Post-operative care influenced by Surgical Apgar Score




Primary Outcome Measures :
  1. Major complications or death [ Time Frame: 30 days ]
    Composite binary outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18y+)
  • General or vascular surgery
  • Elective or emergency surgery
  • Routine outpatient follow-up required

Exclusion Criteria:

  • Those without capacity to consent to involvement in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799369


Sponsors and Collaborators
London Surgical Research Group
National Health Service, United Kingdom
Investigators
Layout table for investigator information
Study Chair: James B Haddow, MRCS London Surgical Research Group
Publications of Results:
Layout table for additonal information
Responsible Party: London Surgical Research Group
ClinicalTrials.gov Identifier: NCT01799369    
Other Study ID Numbers: LSRG-001
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by London Surgical Research Group:
Surgical Apgar Score