The effect of gastric gases discharge on enteral feeding tolerance and function of the gastrointestinal system in patients undergoing mechanical ventilation with nasogastric feeding tube.
The aim of this study was to determine effect of gastric gases discharge on enteral feeding tolerance in patients undergoing mechanical ventilation with nasogastric feeding tube. Inclusion criteria: traumatic patients under mechanical ventilation with CPAP; nutrition with solution prepared in the hospital. Exclusion criteria: Discharge or death of patient; stop gavagbecause of illness; conditions of semi-upright position is prohibited. in this study 60 patients aged 18 - 60 years old.who are admitted in emdadi haspital with GCS less than or equal to 9 under mechanical ventilation with an endotracheal tube and fashion CPAP, will be randomly assigned into intervention or control group. in the intevetion group nasogastric tube connected to a syringe without a plunger kept open 40 cm overhead 30 minutes after gavage, three times with an interval equal to one hour And with hand is pressed as light about 2 cm in epigastric area.The patients in the contorol group do not receive any intervention. Gastric residual volume, abdominal distension, vomiting and diarrhea will be controled before and after the test in both groups. At the end the results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072223291N1
Registration date:2015-11-12, 1394/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Hossein Soltani
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 7422
Email address
soltanih2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gastric gases discharge on enteral feeding tolerance and function of the gastrointestinal system in patients undergoing mechanical ventilation with nasogastric feeding tube.
Public title
The effect of gastric gases discharge on enteral feeding tolerance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patient satisfaction for the study; Age between 18-75 years old; traumatic patients under mechanical ventilation with CPAP; having a nasogastric tube No.14 - 16 ; nutrition with solution prepared in the hospital; have been passed more than 5 days from starting feeding through a nasogastric tube; No history of gastrointestinal surgery or the risk of disorders such as pancreatitis, gastrointestinal ulcers and lesions, gastrointestinal bleeding and gastrointestinal malignancies, liver and kidney failure, sores and infections in the abdomen; The patient not pregnant; No stretch limbs and head, pneumocephalus, diaphragm rupture, hemeuthorax and tension pneumothorax, chest floating, neck and spine injuries; lack of increased intracranial pressure; having GCS less than or equal 9. Exclusion criteria: Discharge or death of patient; stop gavagbecause of illness; conditions of semi-upright position is prohibited.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
ir.gmu.rec.1394.27
Health conditions studied
1
Description of health condition studied
Enteral Feeding Tolerance
ICD-10 code
E63.1
ICD-10 code description
Imbalance of constituents of food intake
Primary outcomes
1
Description
Gastric Residual Volume
Timepoint
Every 3 hrs exactly before doing gavag
Method of measurement
By using 60cc gavage syrige
2
Description
Gastric Distension
Timepoint
Every 3 hrs exactly before doing gavag
Method of measurement
Physical Examination
3
Description
Vometing
Timepoint
Every 3 hrs exactly before doing gavag
Method of measurement
Observation
4
Description
Diarrhea
Timepoint
24 hrs before and after intervention
Method of measurement
Observation
Secondary outcomes
1
Description
Arterial Oxygen Saturation
Timepoint
Every 3 hrs exactly before doing gavage
Method of measurement
By pulse oximetry
2
Description
Tidal Volume
Timepoint
Every 3 hrs exactly before doing gavag
Method of measurement
Ventilator Machine
Intervention groups
1
Description
In the intevetion group: Nasogastric tube connected to a syringe without a plunger kept open 40 cm overhead 30 minutes after gavage, three times with an interval equal to one hour And with hand is pressed as light about 2 cm in epigastric area.The patients in the contorol group do not receive any intervention. Gastric residual volume, abdominal distension, vomiting and diarrhea will be controled before and after the test in both groups. This intervention is done twice a day.
Category
Prevention
2
Description
Cotrol group: Without action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdadi Haspital
Full name of responsible person
Hossein Soltani
Street address
Emdadi Haspital, Fadaein Eslam Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Javad Keramaty
Street address
Gonabad University of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Soltani
Position
Master degree student in critical care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, next to the asian road
City
Gonabad
Postal code
9159814784
Phone
+98 51 5722 2830
Fax
Email
soltanih2@mums.ac.ir
Web page address
www.gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. ali mohammdpour
Position
PHD in Nursing Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 0578
Fax
+98 51 5722 3814
Email
dr.mohammadpour@gmu.ac.ir
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hossein Soltani
Position
Master degree student in critical care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9159813784
Phone
+98 51 5722 2830
Fax
+98 51 5722 3814
Email
soltanih2@mums.ac.ir
Web page address
www.gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)