PAC Time Assessment

• ClinicalTrials.gov Identifier: NCT03451604
• Recruitment Status: Unknown
• First Posted: March 2, 2018
• Last Update Posted: March 2, 2018
• Sponsor: University Hospital, Rouen
• Information provided by (Responsible Party): Vincent COMPERE, University Hospital, Rouen

Study Description

Brief Summary:

The aim of the preoperative assessment clinic (PAC) is to ensure optimal anaesthesia, reduce the morbidity associated with surgery, to increase the quality and decrease the cost of perioperative care 1. In addition, the PAC is an appropriate time to educate the patient on anaesthesia, perioperative care, and pain treatments, to reduce anxiety, to develop care plans, and to obtain informed consent. Moreover, a strong correlation exists between the time spent at the PAC and patient satisfaction2,3.

A high variability of preoperative assessment clinic (PAC) times is a reason for waiting time for patient. A better match between the reserved PAC time and the real consultation time could improved efficiency in consultation theatre. The PAC time depends on various parameters. On average the preoperative assessment of patients with a higher American Society Anesthesiologists' (ASA) class requires more time 4. In other monocentric study, the mean (SD) procedure time was 13 (6) min for the physician. It was significantly longer for patients with a higher ASA class : 10 min for ASA I, 14 min for ASA II, 17 min for ASA III and 21 min for ASA IV patients. In this monocentric study, every patient had a nurse consultation before PAC by the anesthesiologist.

The primary endpoint of this study was to assess the time involved in preoperative assessment clinic included the time during patient's health status has to be assessed (this encompasses a medical history and physical examination) and the time during the patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent.

Condition or disease	Intervention/treatment
Anesthesia; Assessment Time	Other: preoperative assessement

Study Design

• Study Type: Observational
• Estimated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Time Involved in Patient Information During Preoperative Assessment Clinic and Ratio Between Evaluation and Information Times
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2018
• Estimated Study Completion Date: February 1, 2019

Groups and Cohorts

Intervention Details:

• Other: preoperative assessement
  All data concerning study, involved in normal care of patient for his anesthesia (non interventional study), where included in anonymous computerized database by anesthesiologist during pre operative clinic.

Outcome Measures

Primary Outcome Measures :

1. total time involved in preoperative anesthesia consultation (min) [ Time Frame: 30 min ]
   total time (min) is defined by the time between patient entry and discharge from the consultation office. It integrates time for patient assessment (this encompasses a medical history and physical examination) and time for patient information on the benefits and risks of the chosen anesthetic strategy (patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent)

Secondary Outcome Measures :

1. anesthesia and surgery information and patient demographics [ Time Frame: 30 min ]

   Data included anesthesia and surgery information and patient demographics

   • ASA status
   • Age
   • BMI
   • In patient or outpatient
   • Number of medication
   • Number of co morbidity
   • Socioeconomic level
   • Surgical specialty
   • Senior or resident anesthesiologist (year experience)
   • Preoperative anxiety between 0 and 10
   • Patient satisfaction between 0 and 10

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo elective surgery under general or regional anaesthesia

Criteria

Inclusion Criteria:

- Patients scheduled to undergo elective surgery under general or regional anaesthesia

Exclusion Criteria

• patients under 16 years of age
• emergency surgery

Contacts and Locations

Locations

France

Rouen University Hospital; Recruiting

Rouen, France

Contact: Vincent COMPERE, Pr 033 617445203 vincent.compere@chu-rouen.fr

Sponsors and Collaborators

University Hospital, Rouen

More Information

• Responsible Party: Vincent COMPERE, professor, University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT03451604
• Other Study ID Numbers: E2016-74
• First Posted: March 2, 2018
• Last Update Posted: March 2, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No