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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06224231
Other study ID # QM-Patient survey 2024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Charite University, Berlin, Germany
Contact Claudia Spies, MD, Prof.
Phone +49 30 450 55 11 02
Email claudia.spies@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic. The project aims to quality assurance and quality improvement of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin .


Description:

The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis). The survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin from the patient point of view. In order to achieve a meaningful data collection, a response rate of 50 percent should be achieved.


Recruitment information / eligibility

Status Recruiting
Enrollment 2250
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria: - male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey - aged >= 1 years Exclusion Criteria: - unconscious patients, - refusal by patient / parents

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin Berlin
Germany Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin Berlin, Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative stay Postoperative stay is measured by: in post anesthesia care unit/intensive care unit/unknown Time during hospital stay, an average of 2 weeks
Primary Patient satisfaction Patient satisfaction with the care provided by the staff of the CC07; Measurement of satisfaction: Yes/No/Partly Time during hospital stay, an average of 2 weeks
Secondary Campus Campus: CCM or CVK or CBF Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Waiting time in the premedication visit Measurement of waiting time: < 15 minutes, 15-30 minutes, 30-60 minutes, > 60 minutes Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Friendliness of the staff during the premedication visit Measurement of friendliness: Yes/No/Partly Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Information provided during the premedication visit by the anesthetist Measurement of Information: Yes/No/Partly Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Response to questions during the premedication visit Response to questions is measured: Yes/No/Partly Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Fear reduction during the premedication visit Fear reduction is measured: Yes/No/Partly Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Information provided during the premedication visit by educational films Measurement of information by educational films: Yes/No/Partly/No film Time in the outpatient clinic of anesthesia, an average of 1 hour
Secondary Compliance with the planned start of the operation Measurement of compliance with the start of the operation: Yes/No Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Friendliness of staff Measurement of friendliness: Yes/No/Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Fear Fear measured: Yes, very much/Yes, but not much/No fear /Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Thirst Thirst measured: Yes, very much/Yes, but not much/No thirst/Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Pain Pain measured: Yes, strong pain/Yes, but not strong/No pain/Can't remember Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Sufficient pain treatment Sufficient pain treatment measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Shivering Shivering is measured: Yes, strong/Yes, but not strong/No shivering/Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Sufficient therapy in case of shivering Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/ Partly Time in the operation room before start of anesthesia, an average of 30 minutes
Secondary Friendliness of staff Friendliness is measured: Yes/No/Partly Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Post-operative nausea and vomiting (PONV) Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Sufficient therapy in case of PONV Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No PONV/No treatment wanted/Partly Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Pain intensity Pain intensity is measured by likert scale: strong, moderate, low, none Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Sufficient therapy in case of pain Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Shivering Sufficient therapy in case of shivering is measured: Yes/No/Partly Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Sufficient therapy in case of shivering Sufficient therapy in case of shivering is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No shivering/No treatment wanted/Partly Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Post-operative nausea and vomiting (PONV) Measurement of PONV: nausea/vomiting/nausea and vomiting/neither nor Time during hospital stay, an average of 2 weeks
Secondary Regional anaesthesia Measured: Yes / No Time during hospital stay, an average of 2 weeks
Secondary Satisfaction with regional anaesthesia Measurement of satisfaction: Yes/No/Partly Time during hospital stay, an average of 2 weeks
Secondary In case of need choosing of regional anaesthesia again Measurement of choosing again: Yes/No/Perhaps Time during hospital stay, an average of 2 weeks
Secondary Satisfaction of care through pain service Measurement of care through pain service: Yes/No/Partly Time during hospital stay, an average of 2 weeks
Secondary Recommendation of medical care (provided by the staff from CC07) Measurement of recommendation: Yes/No/Partly Time during hospital stay, an average of 2 weeks
Secondary Atmosphere Measurement of atmosphere: calm/busy/can´t remember Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Postoperative fear Measurement of fear: Yes, very much/Yes, but not much/No fear Time in the intensive care unit or post anesthesia care unit, an average of 3 days
Secondary Postoperative pain Pain intensity is measured by likert scale: strong, moderate, low, none Time during hospital stay, an average of 2 weeks
Secondary Sufficient therapy in case of pain Sufficient therapy is measured: Yes, sufficiently treated/ Treated, but not sufficiently/Not treated/No pain/No treatment wanted/Partly Time during hospital stay, an average of 2 weeks
Secondary Postoperative patient controlled analgesia Measurement: Yes/No/I don´t know Time during hospital stay, an average of 2 weeks
Secondary Choosing of Patient controlled anesthesia Question: Would you choose patient controlled anesthesia again? Answer: Yes/No/Maybe Time during hospital stay, an average of 2 weeks
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