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Trial registered on ANZCTR


Registration number
ACTRN12610000243011
Ethics application status
Approved
Date submitted
22/03/2010
Date registered
24/03/2010
Date last updated
3/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
How often should gastric tubes be aspirated in patients in the intensive care unit (ICU) who receive enteral feeding?
Scientific title
Patients in the intensive care unit (ICU) who receive enteral feeding will receive variable regimen of gastric tube aspiration versus usual care to minimise tube handling and improve nutritional targets
Secondary ID [1] 1538 0
Nil
Universal Trial Number (UTN)
U1111-1114-4846
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 256993 0
Condition category
Condition code
Diet and Nutrition 257147 257147 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Variable regimen of gastric tube aspiration. The frequency of gastric tube aspiration in the intervention group will be changed from 4-hourly to 8-hourly once enteral feeding has been established, up to 14 days in ICU or until discharge from ICU, whichever occurs first . If gastric residual volumes are greater than the feed volume administered for the previous 2 hours, 4-hourly gastric tube aspirations will be resumed. If feeding is stopped and resumed at a lower rate than prior to being stopped, the frequency of gastric tube aspirations will revert back to 4-hourly until the feeding target is achieved. All other treatments in the ICU will follow the usual ICU practices for both groups.
Intervention code [1] 256170 0
Treatment: Other
Comparator / control treatment
4-hourly gastric tube aspiration while enteral feeding is undertaken in the ICU (up to 14 days) or until discharge from ICU, whichever occurs first.
Control group
Active

Outcomes
Primary outcome [1] 258039 0
Number of gastric tube aspiration per number of feeding days from the time of feed initiation
Timepoint [1] 258039 0
From time of start of enteral feeding until enteral feeding is ceased or up to two weeks (total time) after enteral feeds are commenced.
Secondary outcome [1] 263619 0
Attainment of target feeding volume per day (day 1 excluded). Data obtained from ICU patient charts.
Timepoint [1] 263619 0
From time of start of enteral feeding until enteral feeding is ceased or up to 16 days (total time) after enteral feeds are commenced.
Secondary outcome [2] 263635 0
Attainment of energy delivery per day (day 1 excluded). Data obtained from ICU patient charts.
Timepoint [2] 263635 0
From time of start of enteral feeding until enteral feeding is ceased or up to 16 days (total time) after enteral feeds are commenced.
Secondary outcome [3] 263636 0
Incidence of vomiting or regurgitatio. Data obtained from ICU patient charts.
Timepoint [3] 263636 0
From time of start of enteral feeding until enteral feeding is ceased or up to 16 days (total time) after enteral feeds are commenced.
Secondary outcome [4] 263637 0
Incidence of ventilator associated pneumonia (up to 16 days after enteral feeding commenced). Data obtained from ICU patient charts.
Timepoint [4] 263637 0
From time of start of enteral feeding until enteral feeding is ceased or up to 16 days (total time) after enteral feeds are commenced.

Eligibility
Key inclusion criteria
Patients admitted to the ICU, who stay in the ICU longer than 48 hours, have a gastric tube inserted, and are likely to receive enteral feeding for three or more days
Minimum age
16 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unlikely to receive enteral feeding for at least 3 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Clinical Nurse Specialists, ICU Research Coordinators and Nurse Shift Coordinators, who are experienced ICU nurses, will liaise with intensivists and screen patients for their eligibility to be recruited into the study. Screened patients who are eligible for inclusion in the study will be randomised by a study Investigator not involved in the clinical management of patients in the ICU. Allocation will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Patient and cohort characteristics were described as mean and standard deviation (SD) or median and interquartile range (IQR) as appropriate. Age, sex, severity of illness and diagnosis were compared between the control and intervention group. Severity of illness was estimated with the worst in first 24 hour Acute Physiology and Chronic Health Evaluation (APACHE) II score.12 The physiological component of the APACHE II score, the Acute Physiology Score (APS), was also examined. Diagnosis (APACHE III diagnostic groups13) was re-grouped into sepsis on admission to ICU (including pneumonia), trauma and other diagnoses. Differences in continuous variables were compared using the Student’s t-test and categorical variables using Chi square. Linear regression was used to examine the number of aspirations per day after adjusting for potential confounders: age, sex, APS, diagnostic group and group (control or intervention) entered simultaneously into the model. The volume of feed received was compared to the prescribed volume for the control and intervention groups. The ICU dietician reviewed all patients in ICU during the working week and prescribed the feed type and volume in liaison with medical staff. The type and volume of feed prescribed was based on the required amount of protein, other nutrients and caloric requirements of the patient, calculated using the Ireton-Jones14 equation. ICU flow charts and incident report forms were examined for the number of splash injuries. All analyses were performed on an intention-to-treat basis. For missing data, the number of available observations was reported. No assumptions were made about the missing data. Data Analysis was undertaken using IBM SPSS version 19.0 (IBM; Chicago, IL) was used to analyse the data. Results were considered statistically significant if the ‘p’ value was <0.05.

Assuming a type I error probability for a two-sided test of 0.05, 80% power, a SD of 1.0, and a reduction in the mean frequency of gastric tube aspirations per 24 hours of 30%, we estimated a sample size of 176 patients per group, i.e. 352 in total. We planned to recruit 360 patients to allow for attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
13/10/2010
Date of last participant enrolment
Anticipated
Actual
16/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256670 0
Other
Name [1] 256670 0
Australian College of Critical Care Nurses
Country [1] 256670 0
Australia
Funding source category [2] 256671 0
Hospital
Name [2] 256671 0
Royal Perth Hospital Medical Research Foundation
Country [2] 256671 0
Australia
Funding source category [3] 287551 0
Charities/Societies/Foundations
Name [3] 287551 0
Western Australian Nurses Memorial Charitable Trust
Country [3] 287551 0
Australia
Funding source category [4] 287552 0
Charities/Societies/Foundations
Name [4] 287552 0
Royal Perth Hospital Foundation for Nursing Research
Country [4] 287552 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street
Perth
Western Australia 6000
Country
Australia
Secondary sponsor category [1] 255970 0
None
Name [1] 255970 0
Address [1] 255970 0
Country [1] 255970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258696 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 258696 0
Ethics committee country [1] 258696 0
Australia
Date submitted for ethics approval [1] 258696 0
Approval date [1] 258696 0
10/03/2009
Ethics approval number [1] 258696 0
2010/008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30958 0
Dr Teresa Williams
Address 30958 0
Critical Care Division Royal Perth Hospital Wellington Street Perth Western Australia 6000
Country 30958 0
Australia
Phone 30958 0
+61 400 212 250
Fax 30958 0
Email 30958 0
Teresa.Williams@curtin.edu.au
Contact person for public queries
Name 14205 0
Teresa Williams
Address 14205 0
Critical Care Division
Royal Perth Hospital
Wellington Street
Perth
Western Australia 6000
Country 14205 0
Australia
Phone 14205 0
+61 400 212 250
Fax 14205 0
No fax
Email 14205 0
teresa.williams@curtin.edu.au
Contact person for scientific queries
Name 5133 0
Teresa Williams
Address 5133 0
Critical Care Division
Royal Perth Hospital
Wellington Street
Perth
Western Australia 6000
Country 5133 0
Australia
Phone 5133 0
+61 400 212 250
Fax 5133 0
No fax
Email 5133 0
teresa.williams@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.