Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05520229 |
| Other study ID # |
Eirunn W. Kristoffersen |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
April 3, 2027 |
Study information
| Verified date |
November 2022 |
| Source |
University of Agder |
| Contact |
Eirunn Kristoffersen, Master |
| Phone |
+4795207238 |
| Email |
eirunn.w.kristoffersen[@]uia.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
International evidence highlights the preanaesthetic assessment clinics (PAC) as a system of
benefits for both the patient and the anaesthesiologist. The system has gained global
acceptance as a routine method of optimising patients' medical conditions prior to surgery
and therefore minimising surgery cancellations and improving hospital efficiency. However, a
systematic review found no evidence of the efficiency of (PAC) and therefore we wanted to
investigate this with the use of hospitals journals.
Description:
The aim of this study is to evaluate the incidence, causes, and consequences of
cancellations, and unanticipated intraoperative events after open or laparoscopic surgery of
hemicolectomy patients before and after the implementation of a preoperative anaesthesia
assessment clinic (PAC).
The primary outcome is to evaluate the incidence of cancellations and unanticipated
intraoperative events after open or laparoscopic surgery of hemicolectomy patients before and
after implementation of the preoperative anaesthesia assessment clinic (PAC).
The secondary outcome is to evaluate the patients' characteristics, the main events leading
to cancellations and the consequences this brings to the patient and the hospital.
Adverse events reported pre-and post-intervention will be analysed. Patient characteristics
will be collected: age, gender, diagnosis, reason and type of surgery, patient admission,
assessed in PAC or not, ASA classification (American Society of Anesthesiologist
Classification system), who performed the assessment (anaesthetic nurse or
anaesthesiologist), type of anaesthesia, former diagnosis/disease with impact on
anaesthesia/surgery, present smoker, allergies, blood samples, other examinations,
cancellation of surgery, reasons and consequences for cancellations, time of anaesthetic
assessment before surgery, intraoperative events, mallampati, Intubation grade, BMI and type
of medication.
A specific data collection form will be developed and the data will be collected
retrospectively from patient journals.
The number is calculated to: n = 588, n = 294 before and after the implementation of PAC. We
use a significance level of 5%. To achieve statistical strength of 80% (beta = 20%), we need
288 patients before and after PAC to detect a difference of at least 10%. Given that we have
the opportunity to include many more then we assume that our study has adequate strength.
Prevalences of cancellations are estimated as shares and presented with 95% confidence
intervals (CIs) calculated using the exact method. Possible differences in background
variables in patients included before and after the implementation of PAC will be estimated
using kji-square tests or t-tests. The effect of the implementation of PAC will be estimated
using logistic regression adjusted for possible confounding factors and results will be
presented as adjusted odds ratio (OR) with 95% CI.
