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Status unknownNCT03451604Updated Mar 2, 2018

PAC Time Assessment

An observational study in Anesthesia and Assessment Time, sponsored by University Hospital, Rouen. Status unknown at 1 site in France. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by University Hospital, Rouen · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia
  • Assessment Time
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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled to undergo elective surgery under general or regional anaesthesia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • patients under 16 years of age
  • emergency surgery
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • Otherpreoperative 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.

05

What researchers measure

Primary outcomes

  1. total time involved in preoperative anesthesia consultation (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)

    Time frame: 30 min

Secondary outcomes

  1. anesthesia and surgery information and patient demographics

    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

    Time frame: 30 min

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03451604
Lead sponsor
University Hospital, Rouen
Responsible party
Vincent COMPERE (professor, University Hospital, Rouen) — Principal investigator
First posted
Mar 2, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
Mar 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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