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Trial registered on ANZCTR


Registration number
ACTRN12618000669291
Ethics application status
Approved
Date submitted
8/04/2018
Date registered
24/04/2018
Date last updated
24/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of a novel peristaltic feeding tube (PFT) in reducing reflux and aspiration of gastric contents in mechanically ventilated patients.
Scientific title
The efficacy of a novel peristaltic feeding tube (PFT) in reducing reflux and aspiration of gastric contents in mechanically ventilated patients.
Secondary ID [1] 294532 0
Nil
Universal Trial Number (UTN)
U1111-1212-0923
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric reflux 307311 0
Ventilator associated pneumonia 307312 0
Condition category
Condition code
Respiratory 306422 306422 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 306529 306529 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, single-center, randomized, open label, controlled clinical study to determine the safety and initial efficacy of the PFT device for the reduction of GER in mechanically ventilated patients in the cardiothoracic intensive care unit (ICU). Institutional ethics approval was obtained (RMC-0378-15). Subjects who meet the study’s entry criteria and have none of the exclusion criteria and who give written informed consent are entered into the trial. This preliminary study will include 10 patients in the treatment group (with PFT) and 10 patients in the control group (with standard nasogastric tube). All subjects are patients who had undergone elective cardiac surgical procedures and who are mechanically ventilated in the ICU afterwards. This allows for a fairly homogenous study population, with no significant lung disease prior to study enrolment. Furthermore, as the procedures are elective, the subjects are able to give consent pre-operatively and so avoid the difficulty of obtaining consent from sedated and ventilated patients. The study will be performed for a total duration of approximately 12 hours in each patient. A randomization list was generated using a computerized algorithm. The randomized sequences were sealed in envelopes prior to study initiation.

All subjects undergo a standard physical examination prior to enrolment to diagnose and document any significant abnormalities or diseases. Patients' demographic and medical information acquired from the subject or their medical chart including age, gender, previous medical history, and prior relevant medical information (such as existence of GERD) are recorded in the study case report form (CRF). Physical examination, laboratory and imaging findings are also recorded in the CRF.

Standard peri-operative blood tests are carried out, with no need for study-specific blood tests. Serum or urine Human Chorionic Gonadotropin (HCG) are assayed in female patients of child-bearing age to rule-out pregnancy. All patients are nursed in the semi-recumbent position in the ICU with the head of the bed elevated to 30 degrees above horizontal for the entire duration of the study, unless a medical need arose for a position change.

In the treatment group the LunGuard PFT is placed in subjects on admission to the ICU by a doctor and correct positioning is verified by X-ray, as described below. The control group has a standard polyurethane nasogastric tube (NGT) inserted as is standard practice for all patients who are mechanically ventilated. Enteral nutritional formula is provided as per unit protocol in both groups, via the central lumen of the PFT or via the standard NGT.

All patients, both the control and treatment groups, are intubated with endotracheal tubes (ETT) that allow suctioning above the ETT cuff (Taperguard Evac tube, Covidien, Colorado).

Study specimens are collected for Pepsin assay by suctioning at the following sites during the period that patients were mechanically ventilated:
From the oropharynx, every hour,
From above the tracheal tube balloon, every hour and
From the trachea, every four hours.
All of these suction samples are then analyzed for the presence of Pepsin A, which as it originates only from the stomach, is a valid marker for secretions of gastric origin. The concentration of Pepsin A is measured using an ELISA immunoassay (Wuhan EIAab Science Co., Ltd, East Lake Hi-Tech Development Zone, Wuhan China).

Placement and management of the PFT –
The PFT is connected to the control management unit (CMU) and a self-test is performed. The results of this test are recorded by the control system and also in the CRF. If the self-test failed, the PFT is replaced. If malfunction continued, the CMU is replaced.

The PFT is placed in treatment subjects on admission to the ICU as we have previously described. In summary, prior to insertion, the physician estimates the distance from the subject's teeth in the midline anteriorly and the gastro-esophageal (GE) junction. The PFT is well lubricated with a water soluble lubricant before insertion. The distal balloon is positioned in the stomach and inflated by the CMU . The tube is then gently pulled back until a significant rise occurs in the internal pressure of the distal balloon as monitored by the CMU (due to the fact that the esophagus/GE junction is of smaller diameter than the stomach). The distal balloon is then deflated and pulled back another 6-7 cm. The goal is to position the distal balloon three to four (3-4) cm above the GE junction). X-ray imaging (the routine post-operative chest x-ray) is then performed to measure the actual location of the distal balloon in relation to the GE. The PFT and its balloons include radiopaque markers that can be detected via X-ray. The PFT is removed upon completion of the study.

As a safety precaution, the device's maximum allowed pressure is not allowed to exceed 25 mmHg under any circumstances via a pressure limiter in the CMU's processor. Adverse events are recorded during the study if they occur.

Esophageal pressure monitoring, which is an intrinsic ability of the PFT device, is noted throughout the study for future integration in mechanical ventilation strategies, as a surrogate measure of pleural pressure, but is not reported as part of this study.

Follow up is performed at 10 days post treatment. The follow up consists of recording any changes in the patient's clinical condition, and any complications, including VAP. VAP is assessed according to the current CDC Guidelines for VAP events. In the event that the patient is released prior to 10 days post treatment, a phone call follow up visit is performed at the 10th day post treatment in order to inquire regarding the patient's general condition, pain possibly related to the device and in particular any evidence of VAP (fever, cough, respiratory secretions, shortness of breath).

Statistics –
Demographic data and Pepsin concentrations for the treatment and control group are compared using T-test analysis. The number of positive Pepsin samples at each site sampled are compared using Chi-Squared Wald testing.

Intervention code [1] 300832 0
Prevention
Comparator / control treatment
The control group receives standard post-operative care with a routine naso-gastric tube
Control group
Active

Outcomes
Primary outcome [1] 305437 0
Change in gastro-esophageal reflux due to use of the peristaltic feeding tube is assessed by measuring the amount of pepsin reaching the upper GIT and airways from the stomach.
Timepoint [1] 305437 0
12 hours from arrival in the ICU after surgical procedure
Secondary outcome [1] 345228 0
The rate of VAP in the treatment and control groups is assessed according to the CDC definitions during the first 10 days - either during the hospital admission (temp., sputum cultures and CXR) or by telephone questionnaire (designed specifically for the study) if the patient is already discharged home..
Timepoint [1] 345228 0
10 days following extubation

Eligibility
Key inclusion criteria
Inclusion Criteria
Eligible subjects must meet all of the following inclusion criteria:
• Ages of eighteen to eighty-five (18-85).
• Informed consent.
• Patients who are expected for at least 12 hours to be:
o Mechanically ventilated and sedated.
o Requiring a nasogastric tube.
• Included are:
o Patients who have undergone tracheostomy.
o Patients who require use of pro-kinetic drugs and proton pump inhibitors.
o All levels of Gastric Residual Volume (GRV)
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Eligible subjects must not meet any of the following exclusion criteria:
• Patients with a contraindication for insertion of a nasogastric tube.
• Patients with a known esophageal obstruction, preventing passage of the device.
• Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para–esophageal hernia, esophageal varices. (not excluded are patients with minor/insignificant GER)
• Acute and severe coagulation disorders
• (INR> 2 or platelets below 30,000)
• Diabetic patients with documented gastrointestinal neuropathy
• Pregnancy or lactation
• Allergy to silicone
• Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient’s participation in this study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is carried out by opaque envelopes containing allocation codes generated by a computer algorthim
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Demographic data and Pepsin concentrations for the treatment and control group are compared using T-test analysis. The number of positive Pepsin samples at each site sampled are compared using Chi-Squared Wald testing.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10262 0
Israel
State/province [1] 10262 0

Funding & Sponsors
Funding source category [1] 299160 0
Commercial sector/Industry
Name [1] 299160 0
Lunguard Ltd
Address [1] 299160 0
Lunguard Ltd
Omer Industrial Park
Omer 84965
ISRAEL
Israel
Country [1] 299160 0
Israel
Primary sponsor type
Commercial sector/Industry
Name
Lunguard Ltd
Address
Lunguard Ltd
Omer Industrial Park
Omer 84965
ISRAEL
Country
Israel
Secondary sponsor category [1] 298415 0
None
Name [1] 298415 0
Address [1] 298415 0
Country [1] 298415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300084 0
Rabin Medical Center
Ethics committee address [1] 300084 0
Rabin Medical Center
Petah Tikve
Ethics committee country [1] 300084 0
Israel
Date submitted for ethics approval [1] 300084 0
01/07/2015
Approval date [1] 300084 0
16/11/2015
Ethics approval number [1] 300084 0
RMC-0378-15

Summary
Brief summary
Gastro-esophageal reflux (GER) is common in ventilated patients and is a cause of ventilated associated pneumonia (VAP). The novel peristatic feeding tube (PFT) uses simulated peristalsis to seal the esophagus to fluid moving in a retrograde manner, whilst allowing normal drainage of fluid and secretions moving in an ante-grade manner. This study describes the first trial of the PFT in ventilated patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82514 0
Dr Phillipe Biderman
Address 82514 0
Assuta Medical Center
7 Harefuah St
Ashdod
7747629
Country 82514 0
Israel
Phone 82514 0
+972505172864
Fax 82514 0
Email 82514 0
philippeb@assuta.co.il
Contact person for public queries
Name 82515 0
Dr Phillipe Biderman
Address 82515 0
Assuta Medical Center
7 Harefuah St
Ashdod
7747629
Country 82515 0
Israel
Phone 82515 0
+972505172864
Fax 82515 0
Email 82515 0
philippeb@assuta.co.il
Contact person for scientific queries
Name 82516 0
Dr Phillipe Biderman
Address 82516 0
Assuta Medical Center
7 Harefuah St
Ashdod
7747629
Country 82516 0
Israel
Phone 82516 0
+972505172864
Fax 82516 0
Email 82516 0
philippeb@assuta.co.il

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary