Safety And Efficacy Of 8 Hourly Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency ; A Prospective Pilot Study
Phase: NA
Conditions: Pleural Effusion
Sponsor: National University of Malaysia

MASTERS IN INTERNAL MEDICINE 
UNIVERSITI KEBANGSAAN MALAYSIA 
 
DISSERTATION: 
SAFETY AND EFFICACY OF 8 HOURLY NORMAL SALINE FLUSHING WITH AND 
WITHOUT HEPARIN LOCK IN MAINTAINING SMALL BORE INTERCOSTAL 
CHEST CATHETER (ICC) PATENCY ; A PROSPECTIVE PILOT STUDY 
ETHICS NO : FF-2024-043 
[SENSHIP TRIAL] 
 
 
CANDIDATE: 
DR YUSRA BINTI HASHIM (P126089) 
 
 
MAIN SUPERVISOR: 
ASSOCIATE PROFESSOR DR MOHAMED FAISAL ABDUL HAMID 
Respiratory Unit, Internal Medicine Department, Hospital Canselor Tuanku Muhriz, UKM 
CO SUPERVISOR: 
ASSOCIATE PROFESSOR DR ANDREA BAN YU-LIN 
DR MAS FAZLIN BINTI MOHAMAD JAILAINI 
DR NG BOON HAU 
DR NIK NURATIQAH NIK ABEED 
DR AZAT AZRAI BIN AZMEL 
Respiratory Unit, Internal Medicine Department, Hospital Canselor Tuanku Muhriz, UKM 
 
ASSOCIATE PROFESSOR DR NOR RAFEAH BINTI TUMIAN 
Hematology Unit, Internal Medicine Department, Hospital Canselor Tuanku Muhriz, UKM 
 
STATISTICIAN ADVISOR: 
PROFESSOR DR SHAMSUL AZHAR SHAH 
Public Health, Epidemiology and Statistics Department, Hospital Canselor Tuanku Muhriz, UKM 

4 
 
TABLE OF CONTENTS 
 
Content 
Page 
LIST OF ABBREVIATION 
5 
CHAPTER 1: INTRODUCTION 
1.1 Research background 
6 
CHAPTER 2: LITERATURE REVIEW 
7 
CHAPTER 3: RESEARCH OBJECTIVE 
3.1 Objectives 
3.2 Significance of research 
9 
CHAPTER 4: RESEARCH METHODOLOGY 
4.1 Type of study 
4.2 Standard of Care 
4.3 Study design 
4.4 Study protocol and data acquisition 
4.5 Operational terms definition 
4.6 Sample size 
4.7 Data collection pathway 
4.8 Dummy table 
11 
CHAPTER 5: RESEARCH ETHICS 
19 
CHAPTER 6: FINANCIAL PLANS 
20 
CHAPTER 7: RESEARCH INFORMATION 
21 
CHAPTER 8: INFORMED CONSENT FORM 
25 
CHAPTER 9: DATA COLLECTION SHEET 
27 
CHAPTER 10: GANTT CHART 
30 
CHAPTER 12: REFERENCES 
31 

5 
 
LIST OF ABBREVIATION 
ICC : Intercostal Chest Catheter 
INR : International Normalised Ratio 
PT : Prothrombin Time 
aPTT : Activated Partial Thrombin Time 
SBICC : Small Bore Intercostal Chest Catheter 
BTS : British Thoracic Guidelines 

6 
 
CHAPTER 1 
INTRODUCTION 
 
 
1.1 Research Background 
Pleural diseases are among the most common clinical problems encountered in 
healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital 
setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for 
a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural 
drainage hence it is important to be aware of safe techniques and procedures of insertion and 
also maintaining the pleural drainage systems to yield beneficial results. 
Most often, smaller catheters were deemed to be less effective in view of slower 
drainage rates and associated with high risk of blockage. However presently , in tertiary 
hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to 
large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less 
painful and easily tolerated by patients. [1] Hence, proper maintenance of SBICC should be 
undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations 
procedures. 
British Thoracic Society in their latest guidelines recommends the use of small bore 
intercostal chest drain as the first choice in draining pleural effusions.[2] However, the success 
of draining pleural effusions with a SBICC has shown variable rates of success among different 
studies conducted. [3] Most common issues faced are drain blockage and drain 
dislodgement.[4] Davies et al in their study suggests regular flushing with normal saline 0.9% 
showed remarkable reduction rates of drain blockage across the study.[5] 
However, there is limited data comparing the use of normal saline flushing versus 
fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining 
pleural effusions. This has lead us in conducting this research to compare the rates of partial or 
complete occlusions among normal saline flush with and without heparin saline lock in 
maintaining the patency of small bore intercostal chest catheter among patients with pleural 
diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains. 

7 
 
CHAPTER 2 
LITERATURE REVIEW 
 
 
According to statistics released by Department of Statistics Malaysia, for the past 3 
years, pneumonia has been on the top 3 as the leading cause of deaths among Malaysians. [6] 
Covid-19 infections being the majority cause of deaths reported in 2022 while Pneumonia was 
reported as the third cause of deaths in 2022 among others.[6] This data again shows the 
importance of managing pleural infections and pleural diseases to improve patient’s general 
outcome and well-being. Pleural effusions may arise from various systemic, inflammatory, 
infectious, or malignant etiologies.[7] Pleural infections are among most common causes of 
pleural effusions that lead patients to seek medical attention in tertiary health care centers. 
British Thoracic Society in their latest guideline insisted on prompt diagnosis of pleural 
effusions and adequate drainage of pleural fluids in symptomatic patients in order to reduce 
rates of morbidity and mortality among patients with parapneumonic effusions. [8] In order to 
achieve the best outcome in lowering mortality and morbidity, adequate drainage of pleural 
fluid from pleural space is the cornerstone of management. British Thoracic Society in their 
guideline again recommends initial drainage of pleural fluid to be undertaken with small bore 
intercostal chest drain. [8] 
Through many literature reviews, there is no exact definition to separate between small 
and large bore intercostal chest catheters. However, SBICC generally referred to chest tubes 
with sizes <16 F and LBICC refers to sizes > 20 F.[10] 
The ideal size of chest tube for management of pleural diseases still remains 
controversial to this day. Many recent researches conducted shows inclination of respiratory 
physician to use SBICC as opposed to LBICC as there are non-inferior to the outcome of 
LBICC. [9] Sumit M. et al , in their study showed comparable success rate in small bore and 
large bore groups respectively in draining pleural effusions. [10] Small bore chest tubes were 
found to be better tolerated by patients when compared to large bore chest tubes, in a study 
conducted by Sumit M. et al observed the mean duration of analgesia administered in a patient 
with small bore chest tubes were much less than in patients with large bore chest tubes. [10] 
However, SBICC were associated with higher rates of complications such as blockage, kinking 
of tubes and also accidental removal. Collop NA, et al in their study suggested blockage rate 

8 
 
of 8.1% in small bore group and 5.2% in large bore group were observed in this prospective 
(non-randomized) study. [11] 
Growing trends in using small bore chest tubes and drainage systems among health care 
providers and pulmonary physicians warrants further research and studies as to minimising 
failures of drainage reported with the use of small bore chest tubes. The British Thoracic 
Society Guidelines recommends frequent and regular flushing of the tubes if small bore chest 
tubes are used. 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. [8] Most tertiary health care centres 
follow this guideline in maintaining the patency of small bore chest tubes. However, this 
guideline only recommends the use of normal saline as a flush. 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. 
A study done by Candice L. et al on the Safety and Efficacy of Fibrinolytics Therapy 
on Restoring Functions of an Obstructed Tunnelled Pleural Catheter, the study concluded that 
instillation of fibrinolytics through a tunnelled pleural catheter into the intrapleural space is 
safe and effective in restoring functions of and obstructed catheter. [12] Flushing and locking 
of catheter tubes has always been a practice strongly associated with catheter blockages 
prevention commonly practices in central venous catheter (CVC). [13] By applying the similar 
principle of using fibrinolytics to maintain patency of SBICC we would like to study the safety 
and efficacy of using heparin saline as locking solution, our aim with this study is to compare 
the safety and efficacy of regular 8 hourly Normal Saline flushing of SBICC with heparin saline 
lock versus without heparin saline lock in maintaining SBICC patency. To the best of our 
knowledge there is no similar study that has been conducted with head to head comparison 
between flushing with heparin saline lock and without heparin saline lock. This study is aptly 
named as SENSHIP Trial , the acronym comes from the title of the research itself - Safety And 
Efficacy Of 8 Hourly Normal Saline Flushing With And Without Heparin Lock In Maintaining 
Small Bore Intercostal Chest Catheter (ICC) Patency. We will refer to the study as SENSHIP 
Trial throughout the period of study and data collection. 

9 
 
CHAPTER 3 
RESEARCH OBJECTIVES 
 
 
3.1 Objectives 
3.1.1 Primary 
1. To compare the rate (in percentage) of partial and complete occlusions of ICC between 
2 groups 
 
 
 
3.1.2 Secondary 
1. To determine the onset of ICC occlusions (in hours) from the time ICC is inserted. 
2. To determine the change of blood parameters (FBC and Coagulation profile) at baseline 
and at 48 hours post ICC insertion. 
3. To determine the associated factors of partial and complete occlusions of small-bore 
cathether. (Eg : Serum LDH level, exudative effusions, different sizes of ICC) 
4. To determine the adverse effects of heparin saline lock. 
5. To assess the number of fenestrations occluded with fibrin or blood clots after the 
removal of ICC. 
 
 
 
3.1.3 Hypothesis 
 
1. Rate of occlusion is less in group with Heparin Saline lock. 
2. Rate of occlusions is higher in patients with exudative effusions. 
- 
Ie : 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. 

10 
 
3.2 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. 

11 
 
CHAPTER 4 
 
 
4.1 Type of Study 
 
RESEARCH METHODOLOGY 
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. 
 
 
4.2 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. [8] 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. 
 
 
4.3 Study Design 
4.3.1 Period of Study 
July 2023 until November 2026 
 
 
4.3.2 Study Setting 
This study will be conducted in all medical wards of Hospital Canselor Tuanku Muhriz., 
HUKM. 

12 
 
4.3.3 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 patients will be randomly allocated into 2 groups : 
a. Group without Heparin Saline Lock 
b. Group with Heparin Saline Lock 
 
The group with heparin saline lock will receive approximately 2mls Heparin Saline as a 
locking solution. 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. 
 
 
4.3.4 Inclusion criteria 
 
All patients admitted in medical wards for pleural effusion who had small bore intercostal 
catheters inserted. 
 
4.3.5 Exclusion Criteria 
 
1. Patients with hydropneumothorax with small bore intercostal catheters 
2. Patients with septated effusion planned for intrapleural fibrinolysis 
3. Patients with severe coagulopathy 
a. INR ε 1.5 
b. PT > 37s 
c. aPTT > 100s 
4. Patients with thrombocytopenia of less than 50 x 109/L 
5. Patients who has not consented to be involved in the study 
6. Patients with indwelling pleural catheters 
7. Unconscious patients will be excluded from this study 
8. Patients with poor GCS score will be excluded from this study 

13 
 
4.3.6 Drop Out Criteria 
1. Patients who had severe coagulopathy after enrollment into the study. 
a. INR ε 1.5 
b. PT > 37s 
c. aPTT > 100s 
 
2. Patients who had developed thrombocytopenia of less than 50 x 109/L after 
enrollment into the study. 
3. Patients refused to participate further into the study after enrollment. 
4. Patients who develop severe bleeding due to other causes after enrollment. 
 
 
4.3.7 Stop Criteria 
1. 
Data collection will stop once ICC is removed. 
 
 
 
4.4 Study Protocol and Data Acquisition 
 
This is a prospective open label randomized controlled trial study of patients 
admitted with pleural diseases in need of small-bore intercostal catheters in Hospital 
Canselor Tuanku Muhriz, HUKM. This study is conducted under the Respiratory Unit, 
Department of Internal Medicine, HUKM. In this study, we would like to compare the rate 
(in percentage) of partial and complete occlusions of small bore intercostal chest catheters 
(SBICC) between 2 groups of patients. 
All patients admitted with intercostal chest tubes will be identified. Among these 
patients, ones that fulfilled the inclusion criteria of this study will be recruited to 
participate. Those patients who had been selected to participate in the study will then be 
randomly allocated into 2 groups of patients. Randomization of patients into respective 
groups will be conducted through block randomization technique. 
Informed, written consent will be taken from the patient, himself, or herself or their 
next of kin once they are agreeable to participate in the study. Written consent for this 
study will be taken prior to the insertion of the ICC for every patients. Once consented, 
data collection on the patient's details, demographic backgrounds will be recorded. Then, 
the primary team of the patients will be informed to facilitate the data collections as per 
protocol designed. 

14 
 
4.5 Operational Terms and Definition 
4.5.1 Small-bore Intercostal Catheters (SBICC) 
For the purpose of this study, small-bore ICC will be defined as drain size <20 F. 
Generally, to date, there is no fixed consensus as to differentiate between small-bore ICC 
and also large-bore ICC as well. 
4.5.2 Large-bore Intercostal Catheters (LBICC) 
Large bore Intercostal Catheter is defined as chest drain sizes >20F. Chest tubes with 
sizes of >20F will not be included in this study. 
4.5.2 Partial Occlusions of ICC 
Partial occlusions of the ICC is defined as : 
- 
Drainage less than 150cc over 24 hours with radiological evidence of persistent 
pleural effusion. 
- 
Needed manoeuvring to effectively aspirate the effusion via the ICC. 
 
4.5.3 Complete Occlusions of ICC 
Complete occlusions of ICC is defined as : 
- Nil drainage of ICC over 24 hours with radiological evidence of persistent pleural 
effusion. 
- Inability to flush the ICC 
 
4.5.4 Change of Blood Parameters 
This study is also designed to determine the outcome and side effects of heparin saline 
as opposed to normal saline flush with regards to change in blood parameters. Some of 
the blood parameters that will be paid attention in this study are : 
4.5.4.1 Thrombocytopenia 
Heparin is well known to cause thrombocytopenia in some patients. Sudden 
drop of platelets counts by 50% from baseline after 48 hours or reduction in 
platelet counts from baseline to less than 50 × 103 /L after 48 hours with 
complete resolution of platelets counts once heparin saline flush is withheld, 
is significant and will be taken into accounts as side effects of heparin flush. 
[13] 
 
4.5.4.2 PT and aPTT Derangement 
Activated partial thromboplastin time (aPTT) and prothrombin time (PT) are 
2 major methods of screening patients for bleeding tendency. Heparin is an 
anticoagulant commonly used for various clinical conditions and will thus 
affect the coagulation profile. Changes in the level of PT and aPTT at the 
beginning of study and after 48 hours will be taken to determine the side 
effects of heparin and normal saline flush on the 2 different parameters. 

15 
 
4.6 
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 by Claire EH 
et al. [13] 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) 
Estimated sample size: 
= 15% 
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 
4.5.1 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. 

16 
 
4.7 
Data Collection Pathway 
Identify patients with ICC in 
medical wards of Hospital Canselor 
Tuanku Muhriz, UKM 
All patients with ICC will be 
screened through and recruited once 
met the inclusion criteria eligibility 
of study. 
Block Randomisation 
 
 
 
 
 
Number of patients 
excluded and reason(s) for 
exclusion. 
 
 
 
Patients randomly allocated 
into Group A 
(Without Heparin Saline Lock) 
Patients randomly allocated 
into Group B 
(With Heparin Saline Lock) 
 
Data Collection Initial Phase: 
o Demographic (Age, Gender, Ethnicity, 
Educational Level) 
o Comorbidities 
o Time (in hours) of ICC insertion 
o Type of ICC and its size 
o Platelets, PT and aPTT level at baseline 
Data Collection Initial Phase: 
o Demographic (Age, Gender, Ethnicity, 
Educational Level) 
o Comorbidities 
o Time (in hours) of ICC insertion 
o Type of ICC and its size 
o Obtain estimated catheter volume to 
lock with heparin saline 
o Platelets, PT and aPTT level at baseline 
 
 
Data Collection Study Phase: 
o Onset of ICC occlusions (in hours) 
from the time of ICC insertion 
o Compare the rate (in percentage) of 
partial and complete occlusions 
between 2 groups. 
o Platelets, PT and aPTT level after 48 
hours 
o To get radiological evidence (ie : 
Thoracic Bedside USG/ Chest Xray) 
before removing the ICC 
o Collects and records the number of 
fenestrations occluded with fibrin or 
blood clots after removing the ICC 
Data Collection Study Phase: 
o Onset of ICC occlusions (in hours) 
from the time of ICC insertion 
o Compare the rate (in percentage) of 
partial and complete occlusions 
between 2 groups. 
o Platelets, PT and aPTT level after 48 
hours 
o To get radiological evidence (ie : 
Thoracic Bedside USG/ Chest Xray) 
before removing the ICC 
o Collects and records the number of 
fenestrations occluded with fibrin or 
blood clots after removing the ICC 
 
 
Data analysis 
Data analysis 

17 
 
4.8 
Dummy Table 
 
Table 1: Baseline demographic data 
 
Characteristic 
Subcategory 
Heparin Saline 
Without Heparin Saline 
N 
% 
N 
% 
Gender 
Male 
Female 
Ethnicity 
Malay 
Chinese 
Indian 
Others 
Comorbidities 
Diabetes 
Hypertension 
IHD 
Stroke 
Heart failure 
OSA 
 
 
 
Table 2 : Pleural Fluid Analysis 
 
Characteristic 
Heparin Saline 
Without Heparin Saline 
N 
% 
N 
% 
N 
% 
N 
% 
Exudative 
Transudative 

18 
 
Table 3: Blood Parameters 
 
Characteristic 
Heparin Saline 
Without Heparin Saline 
0 hours 
48 hours 
0 hours 
48 hours 
N 
% 
N 
% 
N 
% 
N 
% 
Platelets 
aPTT 
PT 
 
Table 4: Outcome Post Removal of ICC 
 
Characteristic 
Heparin Saline 
Without Heparin 
N 
% 
N 
% 
Time of ICC Insertion 
Time of ICC Occluded : 
1)  Partial Occlusion 
2)  Total Occlusion 
Number of fenestrations 
with fibrin/blood Clots 

19 
 
CHAPTER 5 
 
 
RESEARCH ETHICS 
Approval from the Research and Ethics Committee National University of Malaysia granted with 
code FF-2024-043 
 

20 
 
CHAPTER 6 
FINANCIAL PLANS 
 
 
Description 
Allocation per unit (RM) 
Total allocation (RM) 
Printing 
0.2 x 10 x 110 
220 
Heparin Saline 
*Flow Stock Items 
*No extra charges applied 
Total 
220 

21 
 
CHAPTER 7 
RESEARCH INFORMATION 
INFORMATION SHEET FOR PATIENTS (ENGLISH VERSION) 
 
Research title: 
SAFETY AND EFFICACY OF 8 HOURLY NORMAL SALINE FLUSHING WITH AND 
WITHOUT HEPARIN LOCK IN MAINTAINING SMALL BORE INTERCOSTAL CHEST 
CATHETER (ICC) PATENCY ; A PROSPECTIVE PILOT STUDY 
[SENSHIP TRIAL] 
Researcher’s name: 
Dr Yusra binti Hashim / Associate Prof Dr Mohamed Faisal Abdul Hamid/ Dr Mas Fazlin 
binti Mohamad Jailaini 
Place of Conduct: 
Hospital Canselor Tuanku Muhriz, HUKM. 
Introduction: 
Pleural diseases are among the most common clinical problems encountered in healthcare 
settings in Malaysia and even worldwide. Most patients presented in a hospital setting with 
pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of 
reasons. British Thoracic Society in their latest guidelines recommends the use of small bore 
intercostal chest drain as the first choice in draining pleural effusions. However, there is limited 
data comparing the use of regular 8 hourly normal saline flushing with and without heparin 
saline lock in maintaining patency of small bore intercostal chest drains 
Purpose of study: 
The main purpose of this study is to compare the rate of incomplete and complete occlusions 
of catheter between 2 groups. Apart from that, this study is also designed to determine the 
safety of using heparin saline to maintain the patency of the catheter. 
Study conduct: 
You will be given written consent to take part in this study. The data needed for this study will 
be documented and provided by ward staff and monitored directly under supervision of the 
doctor in charge. If you are chosen to receive the non-standard of care therapy (ie : heparin 
saline) , your treatment will slightly deviate from standard of care practiced in the hospital 
because approximately 2ml of Heparin Saline will be use as a locking solution to the catheter 
after each flushing. 
Benefit: 
Your participation in this study may assist physicians in further improvement of medical care 
and techniques in maintaining small bore ICC patency. 

22 
 
Risk: 
Some side effects of regular flushing of Small Bore Intercostal Chest Catheters are mild 
discomfort during the procedure and some may experience slight pain while flushing. Apart 
from that, there is also risk of introducing infection, increment in bleeding risk and also mild 
shortness of breath as fluid was instilled into the pleural cavity 
Participation in this study is entirely voluntary. It is your choice to participate (or allow patients 
to participate). Regardless of your choice, the standard quality of care and treatment remains 
the same. All data obtained will be recorded and will be used for analysis. 
Confidentiality: 
Information collected during this study will be kept confidential. Access to the data is only by 
the research team and Research Ethic Committee of Hospital Canselor Tuanku Muhriz, 
HUKM. No specific reference to any individuals will be reported in this study. Participants 
have the right to know the outcome of this study. 
Reimbursements: 
Participants do not have to pay additional cost in hospital bills. Participants will not be paid for 
participating in this study. 
Right to Refuse or Withdraw: 
This study is a voluntary basis, patients or his/her next of kin have the right to withdraw from 
this study. The choice is yours and all your rights will be respected. 
Disclaimer : 
Insertion of ICC in every patients involved in this study are for treatment purposes and not for 
the benefit of this research only. 
Who to contact: 
Dr Yusra binti Hashim (+60122838157) 
Respiratory Unit, Department of Internal Medicine, Hospital Canselor Tunku Muhriz, UKM. 

23 
 
MAKLUMAT PENYELIDIKAN KEPADA PESAKIT (BAHASA MALAYSIA) 
 
Tajuk Penyelidikan: 
Keberkesanan dan Keselamatan Antara “Heparin Saline Lock” dan tanpa “Heparin Saline 
Lock” Dalam Proses Pembilasan Tiub Untuk Mengekalkan Patensi Tiub Dada Intercostal 
Kecil (ICC) 
[SENSHIP TRIAL] 
Nama Penyelidik: 
Dr Yusra binti Hashim / Associate Prof Dr Mohamed Faisal Abdul Hamid/ Dr Mas Fazlin 
binti Mohamad Jailaini 
Tempat Penyelidikan: 
Hospital Canselor Tuanku Muhriz, HUKM. 
Pengenalan: 
Penyakit ruang rongga paru-paru adalah merupakan antara penyakit yang paling banyak 
ditemui oleh pengamal perubatan di fasiliti kesihatan di Malaysia bahkan seluruh dunia. 
Kebanyakan pesakit yang mempunyai masalah ruang rongga paru-paru memerlukan prosedur 
dimana cairan yang berkumpul di dalam ruang rongga paru-paru perlu dikeluarkan. Di dalam 
garis panduan British Thoracic Society yang terkini, pakar-pakar respiratori sepakat 
mengatakan bahawa penggunaan tiub rongga paru-paru bersaiz kecil adalah pilihan utama 
dalam perawatan pesakit. Namun, terdapat limitasi mengenai data-data menggunakan tiub 
rongga paru-paru bersaiz kecil apabila dibandingkan bersama. 
Tujuan Penyelidikan: 
Kajian ini bertujuan untuk mengetahui lebih lanjut mengenai tahap peratusan oklusi di antara 
2 kumpulan yang berbeza dalam kalangan pesakit-pesakit yang dimasukkan ke wad untuk 
masalah ruang rongga paru paru. Selain itu, kajian ini juga bertujuan untuk menentukan tahap 
keselamatan pesakit yang memerlukan tiub rongga. 
Kaedah Kajian: 
Peserta akan diberikan boring keizinan bertulis bagi menyertai kajian ini. Semasa perjumpaan 
di wad perubatan, kami akan mengambil data sosiodemografik, status penyakit dan senarai 
ubat-ubatan dari rekod perubatan dan sesi temubual. Satu set soal selidik berkaitan kajian akan 
diberikan semasa perjumpaan di dalam wad. Staff di dalam ward akan diberikan set kajian 
mengikut ketetapan. Sekiranya anda terpilih untuk menerima rawatan klinikal dalam kajian 
iaitu Heparin Saline, kaedah rawatan akan sedikit berbeza daripada terapi piawaian yang 
ditetapkan. Anda akan menerima Heparin Saline sebanyak lebih kurang 2ml sebagai cecair 
pengunci kateter untuk memastikan patensi kateter lebih lama. 
Kelebihan: 
Penyertaan pesakit dalam kajian ini akan membantu kami untuk penambah baikan dalam 
rawatan perubatan pesakit yang mempunyai masalah ruang rongga paru-paru 

24 
 
Risiko: 
Terdapat beberapa kesan sampingan daripada procedure ‘flushing’ ini dimana segelintir pesakit 
akan berasa kurang selesa dan juga berasa sakit semasa procedure dibuat. Selain itu, prosedur 
ini juga mempunyai risiko yang rendah di mana berkemungkinan dapat menyebabkan 
jangkitan, risiko pendarahan dan juga sesak nafas semasa prosedur dilakukan. 
Penyertaan anda dalam kajian ini adalah secara sukarela. Ia merupakan pilihan anda untuk 
menyertai kajian (atau membenarkan pesakit untuk terlibat). Walau apa pun pilihan anda, 
segala kualiti rawatan dan perkhidmatan akan diteruskan seperti biasa. Semua maklumat yang 
diperolehi akan direkodkan dan akan digunakan untuk analisa. 
Kerahsiaan Maklumat: 
Semua maklumat yang diperolehi sepanjang anda menyertai kajian ini akan disimpan secara 
Rashia. Semua maklumat hanya boleh diakses oleh pasukan penyelidik dan Research Ethics 
Committee Hospital Canselor Tuanku Muhriz. Tiada maklumat peribadi akan dilaporkan 
dalam kajian ini. Anda juga berhak mengetahui hasil daripada kajian ini. 
Pembayaran balik: 
Tiada kos tambahan akan dikenakan sepanjang tempoh kajian berlansung. Pesakit tidak akan 
diberikan wang imbuhan jika menyertai kajian ini. 
Hak Untuk Menarik Diri: 
Proses penyelidikan ini adalah secara sukarela, pesakit ataupun waris mempunyai hak untuk 
menarik diri daripada kajian pada bila-bila masa sahaja. Hak anda akan dihormati. 
Penafian : 
Penggunaan tiub ICC di dalam kalangan pesakit yang bersetuju menyertai kajian ini adalah 
untuk tujuan rawatan pesakit. Penggunaan tiub ICC bukan untuk tujuan kajian semata-mata. 
Sebarang masalah, sila hubungi: 
Dr Yusra binti Hashim (+60122838157) 
Unit Respiratori, Jabatan Perubatan Dalaman, Hospital Canselor Tuanku Muhriz, HUKM. 

25 
 
 
CHAPTER 8 
INFORMED CONSENT FORM 
SAFETY AND EFFICACY OF 8 HOURLY NORMAL SALINE FLUSHING WITH AND 
WITHOUT HEPARIN LOCK IN MAINTAINING SMALL BORE INTERCOSTAL 
CHEST CATHETER (ICC) PATENCY ; A PROSPECTIVE PILOT STUDY 
[SENSHIP TRIAL] 
 
 
I …………………………………………………… I/C NO: …………................................ 
I have read and understood the ‘Patient Information Sheet’ attached to this ‘Patient Consent 
Form’. Information regarding the reasons for the study, how it will be carried out and the 
inconveniences that are expected has been explained to me. I have been allowed to ask 
questions about this study and these questions have been answered to my satisfaction. 
I understand that my participation in this study is voluntary and I can withdraw myself from 
this study at any point of time during the test. My treatment will be continued and will not be 
affected by my decision to not participate in this study. 
 
I hereby allow the collected information to be analysed in the computer and the information to 
be forwarded to the medical authorities, if necessary. I hereby consent to participate in this 
study 
 
 
 
………………………………………………….. 
Signature / Thumbprint of patient 
Name : …………………………………………. 
IC No : …………………………………………. 
Date  : …………………………………………. 
 
 
 
 
…………………………………… 
………………………………... 
Signature / Thumbprint of witness 
Signature of Doctor 
Name : ………………………….... 
Name 
: ………………………… 
IC No : ………………………........ 
IC No 
: ………………………… 
Date 
: ……………………………… 
Date 
: …………………………… 

26 
 
 
BORANG KEIZINAN PESAKIT 
SAFETY AND EFFICACY OF 8 HOURLY NORMAL SALINE FLUSHING WITH AND 
WITHOUT HEPARIN LOCK IN MAINTAINING SMALL BORE INTERCOSTAL 
CHEST CATHETER (ICC) PATENCY ; A PROSPECTIVE PILOT STUDY 
[SENSHIP TRIAL] 
 
 
 
Saya …………………………………...................  No kad pengenalan …………………….. 
Saya telah membaca dan memahami ’Lampiran Maklumat Pesakit’ yang disertakan bersama 
dengan borang keizinan ini. Maklumat berkenaan tujuan kajian, bagaimana kajian dilakukan 
dan ketidakselesaan yang mungkin dihadapi semasa kajian dilakukan telah diterangkan kepada 
saya. Saya dibenarkan untuk bertanya soalan mengenai kajian ini dan soalan saya telah dijawab 
dengan memuaskan. 
 
Saya fahami bahawa penyertaan saya di dalam penyelidikan ini adalah secara sukarela dan saya 
berhak untuk keluar dari penyelidikan ini pada bila-bila masa ketika kajian dijalankan. Rawatan 
saya akan diteruskan dan tidak akan terjejas jika saya membuat keputusan untuk tidak 
menyertai kajian ini. 
 
Saya bersetuju keputusan kajian ini dikumpulkan dan digunakan untuk analisis berkomputer 
dan diserahkan kepada pihak kesihatan berkenaan. Saya bersetuju untuk menyertai kajian ini. 
 
 
 
 
……………………………………… 
Tandatangan/ Cap jari pesakit 
Nama: ................................................ 
No KP: .............................................. 
Tarikh: ............................................... 
 
 
 
 
 
……………………………............ 
. 
.........…………………………........... 
Tanda tangan saksi 
 
 Tanda tangan pegawai perubatan 
Nama: …………………………….. 
 
 Nama: ………………………………. 
No K/P: ............................................ 
 
 No K/P: ............................................... 
Tarikh: ............................................. 
Tarikh: ................................................ 

27 
 
Characteristics 
Parameters 
 
CHAPTER 9 
DATA COLLECTION SHEET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Timing of ICC Insertion and Removal 
Pleural Fluid Analysis 
 
 
 
Size of ICC : 
 
Time 
(Hours) 
Time of Insertion 
Time of Partial Occlusion 
Time of Total Occlusion 
Time of Removal 
 
4. Blood Parameters 
0 hours 
48 hours 
Platelets 
aPTT 
Patient’s sticker 
Contact number: 
Date: 
1.  Demographic and comorbidities 
2. 
pH 
LDH 
Age 
Gender 
◻ Male 
◻Female 
Ethnicity 
◻ Malay 
◻ Chinese 
◻ Indian 
◻ Others:  
 
Comorbidities 
◻ Diabetes mellitus 
◻ Hypertension 
◻ Ischemic heart disease 
◻ Heart failure 
◻ OSA 
◻ Previous stroke 
◻Others:  

28 
 
 
 
Chest Drain Observation Chart 
Patient sticker here 
 
Drain Side: 
R 
L 
 
• Please use one chart for each drain 
● Total cumulative drainage MUST also be recorded on the Fluid Balance Chart 
● Any variance requires mandatory medical officer (MO) review AND documentation in progress 
notes 
● All bottle changes or flushing should be recorded by a line and descriptor across the observation 
chart row. 
 
EQUIPMENT REQUIRED : 
- Sterile gloves 
- Disposable Dressing Set 
- Sterile 0.9% Sodium Chloride and Heparin Saline 10IU/mL 
- 20 ml Syringe and 3ml Syringe 
- Chlorhexidine solutions 
- Gauze / Cotton 
- Sterile red bung to cap 3 way tap 
 
INSTRUCTIONS : 
1) Check patient prescription sheet regarding type of chest drain lock. 
a. Without Heparin Saline 
b. With Heparin Saline 
2) Identify patient and reconfirm with patient’s wrist tag. 
3) Explain the procedure to the patient. 
4) Wash hands and put on disposable gloves and apron. 
5) Clean and prepare procedure tray 
6) For Group A : 
 
- 
Draw up 20 mls sterile 0.9% Sodium Chloride 
- 
Turn 3 way tap to closed position to outside air 
- 
Remove red cap and clean entry port on 3 way tap with chlorhexidine solution 
- 
Attach sterile syringe to open port and turn to open position (close the drain bottle port) 
- 
Slowly administer 0.9% Sodium Chloride and observe the entry into the cathethers 
- 
Aspirate the volume of flush given and record total aspirate volume in the observation 
sheet. 
- 
Leave the catheter unclamp and record the total drainage volume 
7) For Group B : 
 
- 
Draw up 20mls sterile 0.9% Sodium Chloride 
- 
Turn 3 way tap to closed position to outside air 
- 
Remove red cap and clean entry port on 3 way tap with chlorhexidine solution 
- 
Attach sterile syringe to open port and turn to open position (close the drain bottle port) 
- 
Slowly administer 0.9% Sodium Chloride and observe the entry into the catheter 
- 
Aspirate the volume of flush given and record total aspirate volume in the observation 
sheet 
- 
Administer 2 mls of Heparin Saline as locking solution and recap 
PT 

29 
 
- 
Clamp the catheter subsequently and unclamp after 1 hour, record the total drainage 
volume 
 
 
Date 
Time 
Operator Name 
(HO/MO) 
Flushing Volume 
(mL) 
Aspirate Volume 
(mL) 
Drainage Volume 
(mL) 
Lock Volume 
(mL) 
Frequency of chest drain observations : 8 hourly 

30 
 
Cumulative total drainage (this chart)  
 
 
CHAPTER 10 
 
GANTT CHART 
 
 
Progression/Timeline 
January 2023- 
March 2023 
March 2023- 
August 2023 
August 
2023- 
March 2024 
March 
2024- 
October 
2025 
November 
2025-May 2026 
Literature review and 
proposal write up 
Proposal submission and 
correction 
Presentation to ethics 
committee and approval 
Patient recruitment and 
conduction of study 
Statistical analysis and 
preparation of result 
Manuscript writing and 
submission 

31 
 
 
CHAPTER 11 
REFERENCES 
 
1. 
Horsley A,Jones L, White J, et al, Efficacy and Complications of Small Bore, Wire-guided 
ChestDrains. Chest,2006. 130(1857) : p. 63. 
2. 
Maskell, N. (2010), British Thoracic Society Pleural Disease Guidelines - 2010 
update. Thorax, 65(8), p. 36. 
3. 
Keeling AN, Leong S, Logan PM, et al , Empyema and effusion: outcome of image-guided small- 
bore catheter drainage. Cardiovascular Intervention Radiology,2008 3(135) p. 41. 
4. 
Davies HE, Merchant S, McGown A, A Study of Complications of Small Bore Intercostal Chest 
Drains. Respirology 2008 9 13(3). p.603-607 
5. 
Davies HE, Merchant S, McGown A, A Study of Complications of Small Bore Intercostal Chest 
Drains. Respirology 2008 9 13(3). p.603-607 
6. 
Statistics on Causes of Death in Malaysia (Report 2022) 
7. 
Porcel JM, Azzopardi M, Koegelenberg CF, Maldonado F, Rahman NM, Lee YCG. The diagnosis 
of pleural effusions. Expert Rev Respir Med. 2015;9(6):801–815. 
8. 
British Thoracic Society Guidelines on Pleural Diseases (2010) 
 
9. 
Parulekar W, Di Primio G, Matzinger F, Dennie C, Bociek G, Use of small-bore vs. large-bore 
chest tubes for treatment of malignant pleural effusions. Journal of Bronchology. 2001; 120 : p 
325-326 
 
10. 
Sumit M, Subash H, Dimitar S, Sharon M, Jeffrey B. The Effectiveness of Small Bore Intercostal 
Cathethers Versus Large Bore Chest Tubes in the Management of Pleural Disease with the 
Systematic Review of Literature. Lung India. 2020; 37(3) 198-203 
11. 
Collop NA, Kim S, Sahn SA. Analysis of tube thoracostomy performed by pulmonologists at a 
teaching hospital. Chest. 1997;112: p 709–13. 
12. 
Clare EH, Anthony JE, Anthony W, Amelia OC, Anna M, Paul W, Andrew RL, John EH, Mike D, 
Natalie ZE, Nick AM. Pleural Irrigation Trial (PIT). European Respiratory Journal. 2015; 46 : 456- 
465 
 
13. 
Godelieve Alice Goossens. Flushing and Locking of Venous Catheters ; Available Evidence and 
Evidence Deficit. Nursing Research and Practices. 2015 
 
14. 
Nissar S. Heparin Induced Thrombocytopenia. Journal of Emergencies, Trauma and Shock. 2011 
; 4(1) : 97-102 

32