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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04386733
Other study ID #
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date March 31, 2018

Study information

Verified date May 2020
Source St. Bartholomew's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators prospectively reviewed all same-day cancellations of elective and urgent in-patient adult cardiac surgical procedures from August 2017 to March 2018. Patients were divided into two groups: cancelled (C) and not cancelled (NC). Qualitative patient satisfaction survey was also undertaken.


Description:

This prospective audit was performed over a 7-month period (August - March 2018). A quality improvement team, consisting of two clinical research fellows and a consultant cardiothoracic surgeon, reviewed all the cancellations. The research is reported in line with the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.

Adult patients undergoing elective and urgent cardiac surgery were included in our study. Those who underwent emergency or non-cardiac procedures and patients under the age of 18 were excluded. Patients were identified on a weekly basis from theatre registers and printed operating lists. Same day surgery cancellations were defined as any postponement of patients' operation once listed for surgery.

Electronic hospital records were reviewed, and the following information was recorded for all patients: demographics; scheduled surgery date; euroSCORE II and its components; admission type (elective/urgent in-house/transfer patient); date of pre-operative anaesthetic review. Additionally, reasons for cancellation, timing of cancellation (pre-operative/during anaesthesia/intraoperative) and outcomes were recorded. Outcomes included: time from cancellation to performed operation; hospital stay post-cancellation and mortality. Patients were divided into cancelled (C) and non-cancelled (NC) groups for analysis.

The reasons for cancellation were categorized into: lack of ITU beds and nurses; patient medically unfit; scheduling error; patient-related issues; emergency intervened; procedure no longer needed; lack of perfusionist; incomplete investigations; surgeon unavailable; transfer issue; theatre staff shortage; electrical system failure; new intra-operative TOE findings. Patient-related issues included failure to stop medication and treatment refusal. Scheduling errors included overrunning cases, overbooking of the operating room, late operation start and IT errors.

The investigators further assessed the impact of cancellations on patient satisfaction and wellbeing. Patients completed a questionnaire by telephone at 3 months after discharge to allow time to reflect. Questionnaire data assessed adherence to Association of Anaesthetists of Great Britain and Ireland Theatre Efficiency guidance, including healthcare professional informing patients; time offered for explanation; patient understanding and satisfaction as well as perception of being kept nil by mouth (NBM) longer than necessary. (Figure 1) This questionnaire has previously been used by Wasim et al. to assess patient experience following cancelled orthopaedic surgery. A pilot study was conducted to trial the its' validity.

All data was entered into a Microsoft Excel spreadsheet. Statistical analysis consisted of determination of the mean and range for continuous data and percentage quantification for the categorical data. Statistical significance was established using chi-squared test and two-sided unpaired student t-test with p values <0.05 considered significant. The study was approved by the St Bartholomew's Trust Ethics and Quality Improvement Committee. As this was a quality improvement project and information collected did not include personal identifiers, individual consents were not required.


Recruitment information / eligibility

Status Completed
Enrollment 1388
Est. completion date March 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients who were scheduled for elective or urgent cardiac surgery

Exclusion Criteria:

- patients under the age of 18 or scheduled for an emergency cardiac surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention, it was an observational study which looked at the reasons for surgical cancellations
the investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations

Locations

Country Name City State
United Kingdom St Bartholomew's Hospital London

Sponsors (1)

Lead Sponsor Collaborator
St. Bartholomew's Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of cancelled cardiac surgery assessed by number of cancellations frequency and reason for same-day cancellations immediately after the cancellation of the same-day surgery
Primary Reasons for cancellation of cardiac surgery reasons for cancelled cardiac surgeries were checked in patients notes and recorded immediately after the cancellation of the same-day surgery
Secondary Patient's satisfaction and reaction to the cancellation assessed by the Patient Satisfaction Questionnaire evaluation of patient's reactions to cancellations throughout study completion, an average of 3 months
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