AnesthesiaNCT03451604
PAC Time Assessment
An observational study of Anesthesia and Assessment Time, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anesthesia, Assessment Time
- What is being tested?
- preoperative assessement
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients scheduled to undergo elective surgery under general or regional anaesthesia
Who may be able to join
- Patients scheduled to undergo elective surgery under general or regional anaesthesia
Who cannot join
- patients under 16 years of age
- emergency surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen
Vincent COMPERE, Pr, 033 617445203, vincent.compere@chu-rouen.fr
About this study
Official title: Time Involved in Patient Information During Preoperative Assessment Clinic and Ratio Between Evaluation and Information Times
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.
- Conditions
- Anesthesia, Assessment Time
- Being tested
- preoperative assessement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative assessementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent COMPERE, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451604
- Sponsor's protocol ID
- E2016-74
- Status last verified
- Feb 2018
- First submitted
- 2 Jan 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Involved in Patient Information During Preoperative Assessment Clinic and Ratio Between Evaluation and Information Times
- ClinicalTrials.gov ID
- NCT03451604
- Acronym / sponsor ID
- E2016-74
- Conditions
- Anesthesia, Assessment Time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients scheduled to undergo elective surgery under general or regional anaesthesia
Key inclusion criteria (1 listed)
- Patients scheduled to undergo elective surgery under general or regional anaesthesia
Key exclusion criteria (2 listed)
- patients under 16 years of age
- emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative assessementAll 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. | Other | – |
Primary outcome
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)
1 secondary outcome
anesthesia and surgery information and patient demographics
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Assessment Time, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total time involved in preoperative anesthesia consultation (min) (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.