Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05206721 |
| Other study ID # |
245/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2020 |
| Est. completion date |
November 19, 2020 |
Study information
| Verified date |
January 2022 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Standard practice of flushing saline over the patient's secretions following
suctioning is similar to pouring water over grease, leading to motivating bacterial
colonization and proliferation inside the suctioning circuit (i.e., catheter, tube, and
collecting jar), which can then migrate to patient's lung during suctioning procedure causing
ventilator-associated pneumonia (VAP). Therefore, flushing this circuit using an appropriate
disinfectant to prevent bacterial colonization inside it and thus decreasing pneumonia
occurrence has been our crucial investigation idea.
Aim: To investigate the effect of suction system flushing with chlorhexidine (CHX) on the
occurrence of VAP among mechanically ventilated patients (MVPs). Design: This study adopted a
quasi-experimental research design, and a convenience sampling technique was used to recruit
136 patients to conduct this study. Setting: This study was conducted at surgical intensive
care units of Mansoura University Emergency Hospital, Egypt. Results: The intervention group
patients had a lower incidence of VAP (by 48.12%) compared with the control group. Moreover,
the proposed technique was more effective in decreasing the incidence of late-VAP more than
early-VAP. Furthermore, CHX reduced the cost of suction system flushing by 75%. Conclusion:
Suction system flushing with CHX can significantly reduce the occurrence of VAP among MVPs
and reduce the flushing cost. Therefore, this study recommends incorporating CHX into the
daily care of MVPs.
Description:
Research question Does OTSS flushing with CHX reduce the occurrence of VAP among MVPs?
Hypothesis OTSS flushing with CHX will reduce the occurrence of VAP among MVPs compared with
traditional flushing using normal saline.
Aim This study aimed to investigate the effect of OTSS flushing with CHX on the occurrence of
VAP among MVPs.
Research design A quasi-experimental research design was adopted to conduct this study. The
subjects were randomly assigned to either the intervention or control group, and comparative
results were analyzed based upon pre-post intervention follow-up for both groups.
Setting This study was conducted at the surgical ICUs affiliated with a university hospital
in Egypt with 201-bed capacity. There are three surgical ICUs participated in the study; each
one has 10 beds and provides care to patients with surgical and neurological problems, and
multiple trauma injuries. These units are well equipped with advanced technology required for
high quality patients' care. The nurse-patient ratio in these units is nearly 1:2.
Participants Patients admitted to the ICUs who were intubated within the previous 24 hours
and were expected to receive MV support for more than 48 hours were recruited in the study.
Excluded were patients diagnosed with pneumonia at the time of admission and/or having a
Modified Clinical Pulmonary Infection Score (MCPIS) of 5 or greater, patients who had
contraindications to suctioning (i.e., severe hemoptysis, increased intracranial pressure,
and cerebrospinal fluid leaks), patients with pulmonary edema, acute respiratory distress
syndrome (ARDS) and atelectasis because of their pulmonary infiltrate disease
pathophysiology. Additionally, patients known to be allergic to CHX were also excluded.
Sample size calculation The sample size was calculated through DSS Research using a sample
size calculator software, at 5% α error (95.0% significance) and 20.0% β error (80.0% power
of the study). The sample size needed for the study was 136 patients and the patients were
randomly assigned (the even number in the patients' list was assigned to the intervention
group and the odd number to the control group) into two groups (68 in each group): The
intervention group received CHX as the flushing solution for the OTSS. The control group
received normal saline as the flushing using.
Instruments
Two tools were used to collect data for this study:
Tool Ι: "MVPs' assessment Tool"
This tool was developed by the primary investigator (PI) after reviewing relevant literature
(14,17,18). The tool consists of three parts:
Part Ι: "Patients' Socio-demographic and health relevant Data" This part contained
participants' sociodemographic data including age, gender, occupation, educational level, and
smoking habits. Moreover, it covered the participants' health-relevant data, including the
date and reason of ICU admission, medical diagnosis, past medical history, length of ICU
stay, and modified Glasgow Coma Scale (GCS) score.
Part ΙΙ: "Ventilator modalities data" This part included the MV initiation date, artificial
airway used, intubation process (e.g., urgent; or elective), endotracheal tube (ETT) size,
and mode and duration of MV.
Part ΙΙΙ: "Endotracheal suctioning data" This part included the size of SC, type of SC
connector, and duration of the total suctioning procedure.
Tool ΙΙ: "VAP diagnostic criteria sheet" This tool was adopted from Singh et al (19) and was
used to assess the patients for clinical diagnosis of VAP. It included the MCPIS based on
five clinical assessments; each variable is worth 0-2 points including the patient's body
temperature, number of white blood cells, purulence and quantity of tracheal secretions
(i.e., rare secretions, abundant, and purulent abundant secretions), oxygenation (calculated
as PaO2 divided by the fraction of inspired oxygen "FiO2"), and chest radiography finding
(i.e., no infiltrates, diffused infiltrates and localized infiltrates). The points for each
variable of the MCPIS were summed, yielding a total score varied from 0 to 10 for data
analysis.
Validity and reliability The content validity of tool I was assessed by seven experts from
the Critical Care and Emergency Nursing and Medical fields. Accordingly, essential
modifications were applied. Tool II was adopted and has been extensively used in many
studies, which suggesting its validity. The overall reliability of the tool was tested using
Cronbach's alpha test and was 0.798, indicating that the tool was reliable.
Pilot study A pilot study was conducted on 10% of the total sample (14 patients) before
starting the data collection to evaluate the tools' clarity, feasibility, and applicability.
Participants in the pilot study were excluded from the main study sample.
Data collection Official permission to conduct the study was obtained from the responsible
authorities of the study setting after providing a detailed explanation of the study. The PI
interviewed the patients' families on the first day of the patients' admission, during
official ICU visiting hours, and explained to them the nature of the study. Once the next of
kin agreed to allow the patient to participate in the study, the data collection process was
commenced.
Procedure This study was conducted through three phases: assessment, implementation, and
evaluation.
Assessment phase During this phase, an initial assessment was performed by the PI on the
first day for all MVPs using MCPIS to confirm that they did not have pneumonia on admission,
and they were free from the exclusion criteria using tool II "VAP diagnostic criteria sheet".
Implementation phase The PI did not develop a suctioning performance checklist according to
standard guidelines or even ask the staff nurses to modify their current suctioning practices
neither in the study group nor in the control group. This is to ensure that VAP occurrence
was related to the use of CHX as the flushing solution for the suction system effect and not
the modified suctioning technique.
A. Estimating the necessary CHX flushing amount The appropriate amount of CHX gluconate 0.2%
solution required for effective OTSS flushing was investigated by the PI through clinical
trials under the supervision of clinical expertise. The results showed that 40 mL CHX
solution was an adequate amount for OTSS flushing and removal of any stacked secretions in
the suction tube with a length of 1 m and catheter size of 16 Fr (Appendix I).
B. OTSS flushing intervention was performed through the following technique:
The intervention group:
Step I: Although allergic reactions to CHX are relatively rare, a sensitivity test was
performed for the intervention group patients.
Step II: Routine suctioning technique (following the hospital's protocol) was performed on
the patients by the responsible nursing staff.
Step III: The responsible nurse poured 40 mL CHX 0.2% solution from the CHX bottle into a
sterile container (40 mL was marked by the second line in the container).
Step IV: After suctioning the patient's secretions, the responsible nurse inserted the SC
into the 40 mL CHX filled container and flushed the entire suction system with CHX.
The control group:
Following the same above-mentioned steps II, III, and IV. Using traditional normal saline
instead of CHX for OTSS flushing.
Evaluation phase MCPIS was calculated on the 3rd day for E-VAP and the 6th day for L-VAP. The
minimum score was 0, and the maximum score was 10. Patients who obtained scores above 5 were
diagnosed with pneumonia, and those who got scores below 5 were considered free of pneumonia.
For patients who obtained a score of 5 (borderline) with hemodynamic stability, the PI
reevaluated them after 2 more days (8th day). Besides, for hemodynamically unstable patients,
the PI ordered a sputum culture for them on the 6th day to verify their score. Patients with
negative culture results obtained 0 points upon their score (MCPIS = 5) and were considered
free of VAP, whereas those with positive results obtained 2 more points upon their score
(MCPIS = 7) and were considered to have VAP.
Statistical analysis:
The obtained data were coded, computed, and statistically analyzed using Statistical Package
for the Social Sciences (SPSS), version 24. Data were presented as frequency and percentages
(qualitative variables) and mean ± standard deviation (quantitative continuous variables).
Chi-square was used for comparing categorical variables and was replaced with Fisher's exact
test (FET) or Monte Carlo exact test if the expected value of any cell was less than 5.
Student's t-test was used for comparing continuous quantitative variables (two groups). For
continuous quantitative variables that were not normally distributed, median was used as a
central tendency measure. The Mann -Whitney U-test (Z) was used to compare the two groups.
The difference was considered significant at P ≤ 0.05.
Ethical considerations Ethical approval was obtained from the Local Research Ethical
Committee (Ref. No. 245/2020). Informed consent was obtained from the patients' families
(next of kin), who were informed about the study, including the aim, procedure, benefits, and
risks. The voluntariness nature of participation and the right to withdraw at any time
without responsibility were also emphasized to them. Furthermore, the confidentiality of the
participants' personal information was maintained.
