Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency

Hypothesis

1. Rate of occlusion is less in group with Heparin Saline lock. 2. Rate of occlusions is higher in patients with exudative effusions. e.g : Empyema, raised pleural fluid LDH, low pleural pH, positive pleural cultures. 3. Onset of ICC occlusions is lower in group with Heparin Saline lock. 4. There is no difference in blood parameters between 2 groups. 5. There are no apparent adverse effects between 2 groups. 6. Patients in group with Heparin Saline lock have lower numbers of fenestration occluded.

Significance of Research Pleural diseases are among the most common diseases encountered in tertiary hospitals in Malaysia. Healthcare providers will need to provide adequate drainage of pleural fluids to improve the treatment outcome of patients. One of the mainstays of treatment is to ensure adequate drainage by reducing the rate of blockage of chest drains. This study is a pilot study to determine the efficacy as well as to ascertain the safety profile of using normal saline vs heparin saline lock for small bore intercostal catheters among pleural disease patients.

Type of Study Study on the Safety and Efficacy of 8 Hourly Flushing of ICC with and without Heparin Saline Lock in Maintaining Patency of ICC (SENSHIP Trial) is a prospective open label randomized controlled trial , a pilot study of patients admitted with pleural diseases in need of small bore intercostal catheters in Hospital Canselor Tuanku Muhriz, HUKM.

Standard Of Care Current Standard of Care in managing ICC in pleural diseases follows the recommendation of British Thoracic Society Guidelines where it suggests for regular flushing of ICC. The guideline recommends flushing of the tube by instilling 20-30ml of Normal Saline flush every 6 to 8 hours by a three way stopcock. However, this guideline only recommends regular flushing with Normal Saline and no research has been conducted to compare the outcome of effusions drainage and rates of blockage in small bore chest tubes with different techniques of flushing. Despite regular flushing with Normal Saline solutions as recommended, the rate of blockages in ICC still remains high. Hence, by adapting the concept of Heparin Saline Lock in IJC to maintain the patency of the tubing, we would like to study the difference of regular 8 hourly Normal Saline flushing with and without Heparin Saline Lock in maintaining ICC. Participants in this study who are chosen into Heparin Saline Lock arm will be receiving approximately 2ml of Heparin Saline as locking solution in attempt to maintain the ICC tube.

This study will be conducted in all medical wards of Hospital Canselor Tuanku Muhriz, HUKM.

Sampling Population

This study will be conducted among inpatients in medical wards with pleural effusions requiring small bore intercostal chest catheters who had been screened and consented to be involved in this study. All participants will be randomly allocated into 2 groups :

1. Group without Heparin Saline Lock 2. Group with Heparin Saline Lock

The group with heparin saline lock will receive approximately 1-2mls Heparin Saline as a locking solution (depending on the length of catheter). The amount of Heparin Saline lock to be instilled will depends on the estimated catheter volume. After flushing, the catheter will be clamped for 1 hour and then unclamped after 1 hour. Data will then be collected from 2 different groups to be analysed.

Sample Size Sample size is calculated using 'Select Statistical Online Calculator'; using 2 sample comparisons of percentages. There were no previous study comparing the efficacy and safety of Heparin Saline Lock vs Normal Saline Lock in maintaining the patency of small-bore ICC, thus the sample size calculated using the study conducted previous study by Claire. The study reported a 32% reduction in pleural fluid volume on CT over 3 days in the irrigation group compared to a 15% reduction in patients treated with chest-tube drainage alone (p\<0.04).

Estimated sample size for two-sample comparison of percentages

Assumptions:

Alpha = 5% (two-sided) Power = 80% Intervention (Heparin) = 32% Standard (NS) = 15%

Estimated sample size:

n1 (Heparin) = 96 n2 (NS) = 96

Missing data estimated to be 10%, therefore minimum total sample required is 212 (Intervention = 106 , Standard = 106)

However, as this is a pilot study, the estimated sample size taken for this study is 20% from the calculated sample size with missing data estimated to be 10%.

Estimated sample size :

n1 (Heparin) : 20 n2 (NS) : 20

Therefore, minimum total sample needed is 40

Statistical Analysis

Statistical analyses will be performed with SPSS v23 software. Descriptive statistics, such as the frequency (n), arithmetic mean (x), and standard deviation (SD), are presented for normally distributed variables. A 2- sample independent test for mean and proportions will be used to calculate the statistical significance value between the 2 independent groups. Statistical significance was defined as p\<0.05.

• To determine the onset of intercostal chest catheter occlusions (in hours) [Срок оценки: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain]
• To determine the change of hemoglobin (in g/dL) post ICC insertion [Срок оценки: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain]
• To determine the change of platelet (in 10 9/L) post ICC insertion [Срок оценки: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain]
• To determine the adverse effects of heparin saline lock [Срок оценки: From the time of randomization to the time of the end of study up to 30 days post insertion of chest drain]
• To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots [Срок оценки: From the time of randomization to the time of the end of study up to up to 30 days post insertion of chest drain]