NCT02922634

Preoperative Cognitive Screening in Older Spinal Surgical Patients

Completed Results posted Last updated 21 July 2021

What this trial tests

trial testing Mini Cog in Cognitive Impairment in 229 participants. Completed in 9 June 2019.

Timeline

17 April 2017

Primary endpoint
9 October 2018

9 June 2019

Quick facts

Lead sponsor	Brigham and Women's Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	229
Start date	17 April 2017
Primary completion	9 October 2018
Estimated completion	9 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Mini Cog

Conditions studied

• Cognitive Impairment — all drugs for Cognitive Impairment →
• Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →

Sponsor

Brigham and Women's Hospital

Who can join

70 and older, any sex, with Cognitive Impairment or Frail Elderly Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Delirium by Age Primary · up to 3 days post-op

The median ages of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The Confusion Assessment Method (CAM) is a short diagnostic interview for CAM-defined delirium. Delirium is defined as the sudden change in someone's thinking ability that can have devastating consequences and can be very easily missed due to its frequent subtlety. The 4 CAM features assessed by the CAM include: acute onset or fluctuation, inattention, disorganized thinking, or altered level of consciousness.

Group	Value	95% CI
No Delirium	75	73 – 79
Delirium	77	72 – 80

Number of Participants With or Without Delirium by Sex Primary · up to 3 days post-op

Sex of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	94
Delirium	30
No Delirium	70
Delirium	25

Delirium by Body Mass Index Primary · up to 3 days post-op

Median body mass index of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	28	25 – 32
Delirium	30	26 – 34

Number of Participants With or Without Delirium by College Degree Primary · up to 3 days post-op

Counts of patients with a college degree who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	108
Delirium	36

Participants With an ASA Physical Status Score and the Development of Postoperative Delirium Primary · up to 3 days post-op

The ASA Physical Status Classification System assesses and communicates a patient's pre-anesthesia medical co-morbidities and is on a scale of I-VI. This study recruited patients with an ASA physical status of I-III. ASA I is defined as a normal healthy patient, ASA II is defined as a patient with a mild systemic disease, ASA III is defined as a patient with severe systemic disease. ASA physical status of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	105
Delirium	44
No Delirium	59
Delirium	11

Number of Participants With or Without Delirium by Metabolic Equivalent of Task Score < 4 Primary · up to 3 days post-op

Patients with a metabolic equivalent of task (METS) score \< 4 who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method. The METS score is a ratio of the working metabolic rate relative to the resting metabolic rate and is one way to describe the intensity of an exercise or activity. This was assessed by the preoperative or surgical study staff. A score of \< 3 is for light intesity activities, 3-6 for moderate intensity activities, and ≥ 6 for vigorous intensity activities.

Group	Value	95% CI
No Delirium	45
Delirium	25

Delirium by Total Number of Medications Taken at Baseline Primary · up to 3 days post-op

Median total number of medications of patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	8	5 – 10
Delirium	9	7 – 12

Number of Participants With or Without Delirium by Opioid Use Primary · up to 3 days post-op

Patients with chronic use of opioids who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	34
Delirium	21

Number of Participants With or Without Delirium by Alcohol Consumption Primary · up to 3 days post-op

Patients who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method based on alcohol consumption.

Group	Value	95% CI
No Delirium	98
Delirium	27

Number of Participants With or Without Delirium by Presence of Depression Primary · up to 3 days post-op

Patients with depression who did or did not develop post-operative delirium as assessed by the Confusion Assessment Method.

Group	Value	95% CI
No Delirium	26
Delirium	13

Number of Participants With or Without Delirium by Psychiatric History Primary · up to 3 days post-op

Patients with a history of psychiatric disorders who did or did not develop post-operative delirium as assessed by the confusion assessment method.

Group	Value	95% CI
No Delirium	14
Delirium	8

Delirium by Mini-cog Score Primary · up to 3 days post-op

Median mini-cog score of patients who did or did not develop post-operative delirium as assessed by the confusion assessment method. The Mini-Cog is a brief cognitive screening test for visuospatial representation, recall, and executive function. The test involves that includes recalling three words (banana, sunrise, and chair) and a clock drawing. The Mini-Cog has a scale from 0 to 5, a with higher scores suggesting better cognitive performance. One point is designated for each of 3 words recalled and up to two points for the clock drawing component.

Group	Value	95% CI
No Delirium	4	3 – 5
Delirium	4	2 – 5

Sponsor's own description

The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brief Preoperative Screening for Frailty and Cognitive Impairment Predicts Delirium after Spine Surgery.
   Susano MJ, Grasfield RH, Friese M, Rosner B, et al · · 2020 · cited 91× · PMID 32898243 · DOI 10.1097/aln.0000000000003523