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Comparison of the effect of using suction catheter and nelaton catheter in the process of airway suctioning on the hemodynamic status of patients admitted to the intensive care unit

Protocol summary

Study aim
The main purpose of the research:Comparison of the effect of using suction catheter and nelaton catheter in the process of airway suctioning on the hemodynamic status of patients admitted to the intensive care unit The specific objective of the research: 1- Determining and comparing the average Heart Rate (HR), Respiratory Rate(RR), Oxygen Saturation (O2SAT), Diastolic Blood Pressure (DBP) ,Systolic Blood Pressure (SBP), Mean Arterial Pressure (MAP) in the group of suction catheter and Nelanon tube 1 minute before suction, then at 30 seconds, 3 and 5 minutes after suction The practical aims of the research: 1- Preventing or reducing complications caused by airway suction in patients admitted to the intensive care unit 2- Improving the hemodynamic status of patients admitted in the intensive
Design
Repeated measurres cross-over clinical trial, 44 patients, Simple randomization
Settings and conduct
Patients who meet the conditions for entering the study will enter the study after obtaining informed consent. They will be divided into two groups, A and B, by simple random, coin tossing method. Hemodynamic variables will be measured 1 minute before suction, then 30 seconds, 3 and 5 minutes after suction and side effects will be recorded.
Participants/Inclusion and exclusion criteria
GCS<8 Intubation Age 18 to 65 years Having stability in the hemodynamic range Lack of immune system defects, coagulation disorders, history of respiratory problems
Intervention groups
Group A will be suctioned with Nelaton-Nelaton-catheter-catheter sequence Group B will be suctioned with catheter-catheter-Nelaton-Nelaton sequence
Main outcome variables
Improvement of hemodynamic variables Heart Rate (HR), Respiratory Rate(RR), Oxygen Saturation (O2SAT), Diastolic Blood Pressure (DBP) ,Systolic Blood Pressure (SBP), Mean Arterial Pressure (MAP)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230902059327N1
Registration date: 2023-09-11, 1402/06/20
Registration timing: prospective

Last update: 2023-09-11, 1402/06/20
Update count: 0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Raziyeh Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3347 7300
Email address
raz30khazaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using suction catheter and nelaton catheter in the process of airway suctioning on the hemodynamic status of patients admitted to the intensive care unit
Public title
Effect of using suction nelaton catheter and suction catheter on the hemodynamic status
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GCS<8 Patients with hemodynamic stability No immune, coagulation and respiratory system disorders Age range from 18 to 65 years obtaining informed consent
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used by throwing a coin. This method is usually used to create a random sequence in two-group trials. One of the study groups is lion and the other group is considered line, and based on the desired sample size, the same number of coins are thrown and people are randomly assigned to two groups. The person involved in the randomization program will be separate from other researchers, to reduce possible bias.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-way blind intervention, the participants are not informed which group they are in and which intervention (Nelaton tube or suction tube) started first. Each intervention is individually packaged and has an identification number. The probes are supplied in the same boxes in the same appearance and packaging. This method blinds the participants
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular Medical Research Training Center
Street address
Shohada, Square Shahid Qudousi Hospital
City
Nahavand
Province
Hamadan
Postal code
6591869766
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.RHC.1401.059

Health conditions studied

1

Description of health condition studied
Patients admitted to the intensive care unit
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The percentage of hemodynamic index changes compared to the baseline state, in the two studied groups
Timepoint
One minute before suction, then 30 seconds, 3 and 5 minutes after suction
Method of measurement
Monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: suction of each patient 2 times with suction and 2 times with Nelaton catheter
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital in Hamedan
Full name of responsible person
Raziyeh Khazaei
Street address
Shohada Square, Shahid Qudousi Hospital
City
Nahavand
Province
Hamadan
Postal code
6591869766
Phone
+98 81 3326 5601
Email
raz30khazaei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeedeh mazloomzadeh
Street address
Vali Asr (Aj) Ave., next to Mellat Park, Niayesh corner, Shahid Rajaei and Heart Training, Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2340
Email
smazloomzadeh@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
20
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
Iran University of Medical Sciences
Full name of responsible person
Raziyeh Khazaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shohada Square, Shahid Qudousi Hospital
City
Nahavand
Province
Hamadan
Postal code
6591869766
Phone
+98 81 3347 7300
Fax
Email
raz30khazaei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shiva Khaleghparast
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali Asr (Aj) Ave., next to Mellat Park, Niayesh corner, Shahid Rajaei and Heart Training, Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2011
Email
Sh_khaleghparast@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Raziyeh Khazaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shohada Square, Shahid Qudousi Hospital
City
Nahavand
Province
Hamadan
Postal code
6591869766
Phone
+98 81 3347 7300
Fax
Email
raz30khazaei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For the purpose of presenting the article, the data will be accessible by mentioning the source and the name of the researcher.
From where data/document is obtainable
Send to the email address : raz30khazaei@gmail.com
What processes are involved for a request to access data/document
Sending email with attachment, introduction letter and written request from academic or scientific institution, if approved, the data will be sent.
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