Evaluation of the effectiveness of the combined method of nasogastric intubation in unconsiousness and intubated patients compared to the conventional method
Design
Clinical trial with two groups, which includes control (conventional method) and intervention (combined method), the number required for each group is 30 people (60 in total). The patients were randomly divided into 2 control and intervention groups, and the study was one side blinded, and a table of numbers was used for randomization.
Settings and conduct
Sampels will be taken in Hashminejad and Imam Reza emergency departments Mashhad.
A one side blinded study with only patients being blinded.
Participants/Inclusion and exclusion criteria
Intubated and unconsciousness patients who need a nasogastric tube
The person is at least 18 years old and does not have active bleeding, coagulation problems, or esophageal varices
Intervention groups
NG tube placement with new combined method
Main outcome variables
success rate ; NG tube placement time; Immediate complications of Ng placement; Number of attempts for NG placement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230623058561N1
Registration date:2023-11-07, 1402/08/16
Registration timing:prospective
Last update:2023-11-07, 1402/08/16
Update count:0
Registration date
2023-11-07, 1402/08/16
Registrant information
Name
saeed razghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 728 2429
Email address
razghandis3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency of The Combined Method of Nasogastric Tube Insertion with The Conventional Method in Unconscious Intubated Patients
Public title
New combined method for Ng insertion in Unconscious Intubated Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Order of physician for Ng tube insertion
age more than 18
patients must be intubated
patient must be unconsciousness and not cooperating ( GCS<9 or Ras < -2 or ACVPU = U )
Dose not have current bleeding
Dose not have any fractures in base skull
Dose not have esophageal varices
Not having recent surgeries in esophageal area
Exclusion criteria:
Unstable hemodynamics when patient need resuscitation
Narrowing or deviation of nostrils ( The NG tube dose not go forward in esophagus by nostrils )
Bradycardia ( HR <60)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
1. Selection of a foreigner
2. Using the table of random numbers according to the sample size
3. Odd numbers are assigned to the control group and even numbers are assigned to the intervention group
Blinding (investigator's opinion)
Single blinded
Blinding description
People participating in the research and under the study are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad University of Medical Sciences
Street address
15 Abolkheir Ave. 17 North motahari Blvd. 3Block Mashad city
City
Mashad
Province
Razavi Khorasan
Postal code
9193754688
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.088
Health conditions studied
1
Description of health condition studied
NG tube insertion in intubated and unconsciousness patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the number of success in NG tube placement in the combined method with the conventional method
Timepoint
Immediately after NG insertion
Method of measurement
Checking the correct placement by Injecting 20cc of Bolus air into Tube and checking the bulb sound in stomach by stethoscope
2
Description
Comparing the number of attempts to insert the tube in the combined method with the conventional method
Timepoint
Immediately after NG insertion
Method of measurement
Correct NG tube Placement on the first or second attempt is considered a success. Each attempt is equivalent to a duration of less than 90 seconds
3
Description
Comparison of the elapsed time for tube placement in the combined method with the conventional method
Timepoint
Immediately after NG insertion
Method of measurement
Placement time measurement with chronometer
4
Description
Comparison of immediate complications caused by tube placement in the combined method with the conventional method
Timepoint
Immediately after NG insertion
Method of measurement
Immediate complications include bleeding due to traumatization, twisting of the tube, bradycardia during tube placement, entering the nasogastric tube into the trachea, which is measured after tube placement.
Secondary outcomes
empty
Intervention groups
1
Description
1. In the combined method, first, the tube that is kept at 4 degrees is filled with cold normal saline (4 degrees) with the help of a gavage syringe, and the tube is clamped to prevent the saline from escaping and to prevent the tube from heating up over time the NG tube will be place in a duration of less than 60secounds after exiting the refrigerator and the temperature of tube will be measured before placement .2. The tube enters the nostril at 90 degrees and in the hyperextension position from the side opposite to the entrance of the tracheal tube in the pharynx, so that if the tracheal tube is in the left part of the pharynx, it is entered through the right nostril.3. After the beginning of the tube reaches the nasopharynx, the patient's head changes to flexion and is turned to the opposite side of the tracheal tube relative to the position of the lips, so that if the tube is fixed in the corner of the left lip, the neck is turned towards turns right 4. In the mentioned position, nasogastric intubation continues until the marked amount reaches the patient's stomach. The amount of tube placement is calculated by the zen+10 method .5. The normal saline in the tube is aspirated and the correctness of intubation is controlled.6. The correctness of intubation is done by injecting 20 cc of air quickly and confirming the sound in the stomach by auscultation of the stomach. IN case of failure in the first attempt within 90 seconds, intubation is performed with the failed method. In case of failure after two attempts, intubation failure is recorded and then intubation is done with the help of usual methods or other methods by nurses or doctors.
Category
Treatment - Devices
2
Description
In the control group, nasogastric intubation is performed in unconscious patients and intubation is performed in the conventional way (blind insertion).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Imam Reza hospital
Full name of responsible person
Saeed Razghandi
Street address
Doktora Corss road. Imam Reza hospital . Mashad city
City
Mashad
Province
Razavi Khorasan
Postal code
91379 13316
Phone
+98 51 3854 3031
Email
saeedra627@Gmail.com
2
Recruitment center
Name of recruitment center
Emergency department of Hasheminezhad hospital
Full name of responsible person
Saeed Razghandi
Street address
Aboreihan Blvd. Hasheminezhad Hospital. Mashad city
City
Mashad
Province
Razavi Khorasan
Postal code
8886991557
Phone
+98 51 3273 7012
Email
saeedra627@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice president of research and technology
Street address
Azadi Square , Mashad city , Khorsan Razavi Province
City
Mashad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
razghandis3@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?