Determining the effect of a scoring system and anesthesia expert guidance on early diagnosis and intervention in the post-anesthesia care unit
Design
A clinical trial with a control group with parallel groups, randomized, on 50 patients
Settings and conduct
The present study is a randomized controlled trial in PACU of one of Ahvaz teaching hospitals. The statistical population of this study consists of all patients who will undergo abdominal and thoracic surgery and then be monitored in PACU.
Random division of patients is done in the preoperative period. To achieve an equal distribution of patients in the groups, randomization will be performed after determining the total number of patients undergoing surgery on the same day. To do this, patients are asked to pull out a sealed envelope with the study or control group written on it.
Participants/Inclusion and exclusion criteria
Including age over 18, volunteering to participate in this study, undergoing general anesthesia for abdominal or chest surgery, no history of general anesthesia in the past 6 months, and no intraoperative complications
Intervention groups
All patients are scored according to EWSS during the PACU course. Patients in the control group do not receive any intervention as directed by the anesthesiologist's guide, even if they have a high score. Patients in the study group receive the necessary interventions as indicated in the anesthesiologist's guide.
Main outcome variables
Patients' EWSS score; Length of stay in the PACU; Complications in the PACU; Complication treatment time; Treatments performed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050463N1
Registration date:2021-03-06, 1399/12/16
Registration timing:prospective
Last update:2021-03-06, 1399/12/16
Update count:0
Registration date
2021-03-06, 1399/12/16
Registrant information
Name
Noushin Sarvi Sarmeidani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3390 6395
Email address
sarvi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-20, 1399/12/30
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Impact of a Scoring System and Anesthesia Guide on Early Diagnosis and Intervention in the Post Anesthesia Care Unit
Public title
A guidance system in the post-anesthesia care unit
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Volunteer to participate in this research
Under general anesthesia for abdominal or chest surgery
Exclusion criteria:
Have a history of general anesthesia in the last 6 months
Having a threatening surgical complication during the operation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the patients was performed during the preoperative period. The patients were requested to draw one of the two sealed envelopes; one denoting the study group and the other denoting the control group. To achieve equal distribution of the patients to the groups, Simple individual randomization was performed after the total number of patients who would undergo the operation at the same day was determined. If the total number of patients was 6 on a certain day and 3 of them drew the study group envelope, the rest of the patients were just allocated to the control group without drawing envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Approval date
2021-02-05, 1399/11/17
Ethics committee reference number
IR.AJUMS.REC.1399.891
Health conditions studied
1
Description of health condition studied
Cardiopulmonary complications
ICD-10 code
R00-R09
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems
Primary outcomes
1
Description
Early warning scoring system score
Timepoint
Data for this period are collected after the patient is admitted to the PACU
Method of measurement
1. Calculating the EWSS score of patients In this study, an anesthesiologist's guide is used, this guide has been prepared to achieve the standard of care by referring to published articles.
2
Description
length of stay in PACU
Timepoint
Data for this period are collected after the patient is admitted to the PACU
Method of measurement
Record patient results: length of stay in PACU
3
Description
Complications created in the PACU
Timepoint
Data for this period are collected after the patient is admitted to the PACU
Method of measurement
Record patient results: Complications of PACU (respiratory, pain, hypotension, nausea and vomiting, etc.)
4
Description
Complications treatment time
Timepoint
Data for this period are collected after the patient is admitted to the PACU
Method of measurement
Record patient results: Treatment time of patients' complications in recovery in minutes
5
Description
Treatments performed
Timepoint
Data for this period are collected after the patient is admitted to the PACU
Method of measurement
Recording patient results: treatments performed for the patient by anesthesiologist (respiratory intervention, fluid therapy, positioning, additional tests, etc.)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the study group receive the necessary interventions as indicated in the anesthesiologist's guide. If the score is EWSS≤4, the patient is monitored every 10 minutes. If the patient's EWSS score is 5, the patient is monitored every 5 minutes. If the patient's score does not change, monitoring is continued every 5 minutes. However, if the patient's score drops to ≤4, monitoring is performed every 10 minutes. If the score increases, the follow-up will continue for 5 minutes and the emergency team will be called to evaluate the patient.
Category
Early detection
2
Description
Control group: All patients are scored according to EWSS during the PACU period. Patients in the control group do not receive any intervention as directed by the anesthesiologist, even if they have a high score.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Teaching Hospitals
Full name of responsible person
Ali Khalafi
Street address
Ahwaz Jundishapur University
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Biranvand
Street address
Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com
Grant name
Research committee of Ahvaz Jundishapur university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Email
nooshinsarvi9192@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Noushin Sarvi Sarmeidani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Jundishapur Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6143975617
Phone
+98 61 3390 6395
Fax
Email
sarvi.n@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available