Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation

Design

Retrospective, cohort quality assurance study

N= 205

Objective

To evaluate the effectiveness of an alkalinized solution of the new formulation of Viokace® in clearing enteral feeding tube obstructions according to updated procedures

Study Groups

All patients (N= 205)

Occluded tubes (n= 277)

Inclusion Criteria

Adult and pediatric patients admitted to the study institution or seen in the emergency department, prescribed an alkalinized solution of clearing occluded enteral feeding tubes 

Exclusion Criteria

Did not receive Viokace as prescribed or received Viokace for any indication other than clearance of occluded enteral feeding tubes, cases involving physical obstructions of the tube (e.g., kinked tubes)

Methods

All pertinent data were collected from electronic medal records. If flushing the tube with warm sterile water and clamping for 5 minutes did not clear the occlusions, the institutional protocol used for clearing occluded enteral tubes was as follows:

1. Thoroughly crush and dissolve one Viokace (10,440 lipase units/39,150 protease units/39,150 amylase units) pancreatic enzyme tablet and one sodium bicarbonate 325 mg tablet in 5 mL warm sterile water.

2. Instill the pancreatic enzyme/bicarbonate solution using light pressure and clamp the enteral feeding tube for 5–15 minutes.

3. Use warm sterile water to aspirate or flush the tube. A light “back and forth” motion with the syringe plunger is suggested in order to dislodge the clog.

4. The procedure may be repeated if needed.

The tube clearance protocol was deemed ineffective if documented as such in the medical record or if the enteral feeding tube was removed or replaced following administration of the pancreatic enzyme solution.

Duration

Hospital admission or seen in the emergency department: September 1, 2014 to August 31, 2015

Outcome Measures

Percentage of occluded tubes successfully cleared

Baseline Characteristics

All patients (N= 205)

Median age, years (range)

Female

Enteral feeding tube type

Dobhoff

Nasogastric

Nasojejunal

Jejunostomy

Gastrostomy

Gastrojejunostomy

43.6%

14.8%

11.6%

11.2%

9.7%

7.9%

Specific causes of obstruction were not documented frequently. The most common causes included enteral nutrition (17 cases) and medications (13 cases).

Results

Endpoint

Occluded tubes (n= 277)

Successful clearance of occluded tubes

In 25 of the 277 cases, the protocol was repeated after the initial Viokace instillation was ineffective, resulting in the clearance of 10 occlusions. In 6 cases, the Viokace protocol was administered a third time, successfully clearing 5 additional enteral feeding tubes. 

The efficacy of the protocol was not affected by patient age (adult vs. pediatric, p= 0.0635) or type of enteral feeding tube (p= 0.215).

Adverse Events

Study Author Conclusions

According to this retrospective evaluation, an alkalinized Viokace pancreatic enzyme protocol was effective in clearing 63.5% of occluded enteral feeding tubes. This significantly higher success rate than previously documented with a Creon-based protocol supports the change in pancreatic enzyme formulations in the institutional protocol.

InpharmD Researcher Critique

Unclogging Feeding Tubes with Pancreatic Enzyme

Design

Prospective, single-arm study

N= 90 patients followed; 32 patients with tube occlusions; 44 declogging attempts

Objective

To evaluate possible causes of tube occlusion and to assess the efficacy of an activated pancreatic enzyme solution to clear obstructed feeding tubes

Study Groups

All patients (N= 90 patients followed; 32 patients with tube occlusions)

Inclusion Criteria

Patients receiving enteral feeding through a Dobbhoff tube

Exclusion Criteria

N/A

Methods

Patients receiving enteral feeding through a Dobbhoff tube were followed daily over an 8-month period to monitor for tube clogging. Declogging of obstructed feeding tubes was attempted within 24 hours or as soon as the nutrition support team was notified. Declogging was done by inserting a Drum cartridge catheter (Abbott Laboratories, North Chicago, IL) into the occluded feeding tube to inject the declogging solution. Water was injected first, and the feeding tube was clamped for five minutes. If the tube failed to unclog, a pancreatic enzyme solution was injected near the formula clot to displace any liquid formula close to the obstruction site and unclog the tube. The feeding tube was also clamped for five minutes after injection of the pancreatic solution. Afterward, a 50 mL syringe was attached to the feeding tube using an adapter and flushed gently with tap water to regain patency. Patients were followed until the removal of their feeding tubes, and inspection of the feeding tubes revealed no cases of tube perforation.

The pancreatic enzyme solution was made by crushing one tablet of Viokase and one tablet of sodium bicarbonate 324 mg and dissolving the powder in 5 mL of warm water prior to injection into the catheter. 

Duration

Enrolment: 8 months

Follow-up: until removal of feeding tube

Outcome Measures

Successful declogging

Baseline Characteristics

All patients (N= 90 patients followed)

Age, years

Female

Feeding tube occlusion

Occluded tube location

Stomach

Duodenum

78%

12%   

Results

Endpoint

Water

Pancreatic enzyme

Tube declogging*

Success

Failure

12 (27%)

32 (73%)

23 (72%)

9 (28%)

p< 0.01 (Fisher's exact test).

Thirty-two patients with small-bore feeding tubes experienced 60 episodes of tube occlusion, and the nutrition support team was notified for declogging in 44 cases.

The reason for failure to clear the occluded tubes with pancreatic enzyme solution was determined in seven cases and included tablet impaction (three cases), knotted feeding tube (two cases), tomato seed occluding the feeding port (one case), and formula clot in 2/3 length of the tube for 24 hours (one case). 

Adverse Events

Not disclosed

Study Author Conclusions

Activated pancreatic enzyme solution, when applied close to the clotted formula, has a 96% success rate in clearing the obstruction in cases where water failed.

InpharmD Researcher Critique

The study demonstrated the successful declogging of enteral feeding tubes using a Viokase solution. 

Efficacy of a Creon Delayed-Release Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes

Design

Retrospective, quality assurance study

N= 83 (118 clogged tubes)

Objective

To evaluate the effectiveness of a Creon (pancreatic enzyme delayed-release capsule)-based protocol to clear occluded enteral feeding tubes

Study Groups

Study participants (N= 83)

Inclusion Criteria

Exclusion Criteria

Not received the prescribed dose of Creon delayed-release capsules (i.e., either the standard 12,000 units lipase or another dose) or received Creon for another indication

Methods

Given the inaccessibility to previously used Viokase, the institution changed its protocol switching to Creon delayed-release capsules (lipase 12,000 units, protease 38,000 units, and amylase 60,000 units) for clearing occluded enteral feeding tubes. Specific protocol procedures are listed below: 

1. Thoroughly crush a single sodium bicarbonate 650-mg tablet and dissolve it in 5 to 10 mL sterile water. This will take approximately 3 to 5 minutes. There will be some precipitate in the water, likely from the tablet excipients
2. Once dissolved, open 1 Creon capsule and empty the granules into the water/bicarbonate mixture. Allow to dissolve, which will take about 5 minutes or longer. The mixture will turn a light brown color, the same color as the Creon granules
3. Once prepared, use this pancreatic enzyme/bicarbonate solution, instilling under light pressure and clamping for 5 to 15 minutes. Then, use warm sterile water to aspirate or flush the tube. A light “back and forth” motion with the syringe plunger is suggested in order to dislodge the clog

The dispensing database was retrospectively reviewed to identify eligible patients and collect relevant demographic and clinical data. Efficacy was defined as documentation in the medical record of tube clearance or resumption of enteral feedings with no note regarding tube replacement. A failure of the protocol was determined if the occluded tube was removed and/or replaced following administration of the pancreatic enzyme solution. 

Duration

Between May 1 and November 30, 2010

Outcome Measures

Primary: efficacy of the Creon protocol (percentage of occluded tubes successfully cleared), effect of the dose of Creon administered on the outcome

Baseline Characteristics

Age, years

Female 

Location of administration

Emergency department 

Medical services 

Surgical services

7.2%

39.8%

53%

Types of feeding tube 

Dobhoff

Jejunostomy

Percutaneous endoscopic gastrostomy

51.8%

18.1%

13.3%

Causes of enteral feeding tube obstruction

Tube coiling

Kinked tubes

Enteral nutrition

Medications

Nasogastric tube bridle placement issues

Undocumented 

3 (2.6%)

2 (1.7%)

2 (1.7%)

1 (0.9%)

1 (0.9%)

106 (92.2%)

Results

Endpoint

Efficacy 

Dose of Creon administered, doses 

12,000 lipase units

6,000 lipase units

24,000 lipase units

112/121 (92.6%)

6/121 (5%)

3/121 (2.5%)

Following Creon's failure, the alternative method was also not effective in clearing the obstruction in 10 of 13 (76.9%) cases, and the tube was subsequently removed or replaced. Enteral feeding tube removal or replacement was documented in 11 (17.7%) and 36 (58.1%) of 62 cases, respectively.

Adverse Events

Study Author Conclusions

An alkalinized Creon pancreatic enzyme protocol was effective in clearing approximately half of the occluded enteral feeding tubes in this retrospective study, an efficacy rate much less than that previously reported in the literature with a Viokase-based protocol.

InpharmD Researcher Critique

While not specific to Viokase, the study demonstrated the feasibility of a Creon-based protocol when Viokase became unavailable. The retrospective, single-center experience may limit results, potentially confounded by other factors.