Nurse's RoleNCT06812182
Effect of Nurse Guided Enhanced Recovery Clinical Pathway on Respiratory Infection
A study testing nurse guided clinical pathway in people with Nurse's Role, run by Assiut University at 1 site in Egypt.
Trial summary
Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery [ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training]. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- nurse guided clinical pathway
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to communicate
- Patients without vital failure [renal, hepatic, cardiac].
Who cannot join
- Past history of other organ cancer
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness a Nurse Guided Enhanced Recovery Pathway on Postoperative Respiratory Tract Infection in Hepatico-Pancreatic -Biliary Surgery
Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery [ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training]. Design: Quasi-experimental study. Setting: The study was conducted in surgical department, operation unit and intensive care unit at AlRajhy liver hospital. Subjects: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group (30patient each). The control started the first then the study group. Tools: Three tools were used. Tool I: Patient assessment sheet. Tool II: Clinical pathway protocol. Tool III: Clinical outcome evaluation. The control group received tools I and III only while study group received the three tools including clinical pathway protocol [tool II].
Read the detailed description
: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group [30patient each]. The control started the first then the study group.
The sample size was calculated according to Epi Info 2000. A sample size was selected using a special formula based on prevalence of disease at a confidence interval of 95% and precision of (2%). The sample was increased by 10% to overcome problems related to non-responses and missing data. The power of study was 80%. Considering the following matching criteria age group, sex, diagnosis, comorbidity diseases.
The patients' inclusion criteria: Age 18-65 years old, able to communicate and Patients without vital failure [renal, hepatic, cardiac].
The patients' exclusion criteria: Past history of other organ cancer and patient refusal.
Tools:
Tool one; Patient assessment sheet:
This tool was developed by researchers based on related literature to assess the surgical patient[11]. It consisted of three parts Part1: it included socio-demographic data about the patients such as: age, gender, level of education, material status and clinical data such as patient diagnosis, past medical history, past surgical history, surgical procedure and type of anesthesia.
Part 2: Intra¬¬-operative data which included estimated blood loss, urine output, fluid and blood replacement, final balance, intraoperative complications, duration of anesthesia, duration of surgical procedure and duration of recovery.
Part 3: Post-operative assessment that included:
Physical assessment included anthropometric measurement [weight, height and body mass index] body mass index measured through dividing weight by kg on the square of height by m2, vital sign [temperature, pulse, respiration, blood pressure] Monitoring Signs of respiratory infection [cough, dyspnea, hypoxemia, tachypnea] and the need to oxygen therapy were also recorded besides monitoring arterial blood gases.
Tool two [the main research investigation] = named as clinical pathway protocol:
Clinical pathway for hepatobiliary pancreatic surgeries, this tool was developed by researchers after extensive review of related literatures and enhanced recovery after surgery pathway. The researchers used enhanced recovery after surgery to develop this tool. This tool was applied on the study group only. The six-time intervals included the three perioperative stages: the first interval represented the preoperative period, the second interval represented the intraoperative period and the next four intervals represented the postoperative period [over three days after surgery, hospitalization period]. This tool format was prepared in a matrix form that included vertical column representing applicable or not applicable and horizontal row clinical pathway items (as discussed later).
This tool consisted of three phases:
Pre-operative phase; counseling and education of patient for chest physiotherapy, using spirometry, bowel preparation, early mobilization and how to predict common complications with learning to cooperate with nurses. Emphasis on patients to co-operate postoperatively was strongly stressed in spite of the pain and weakness.
Intra-operative phrase: Optimal fluid management, short acting anesthetics, regional analgesia, opioids-sparing anesthesia, small incisions, avoiding drains, maintaining normothermia, venous thrombo-embolism [VTE] prophylaxis and antibiotic prophylaxis were routinely done.
Post-operative phase components: Early oral nutrition, optimal fluid management, multimodal non-opioid analgesia, postoperative nausea and vomiting PONV prophylaxis, stimulation of gut motility, early removal of catheters and drains, early mobilization, chest physiotherapy and using spirometry effectively.
3-Tool three: clinical outcome evaluation: This tool developed by researchers based on reviewing the recent related literature [4]. It was aimed to assess the clinical outcomes for hepatobiliary pancreatic patients three days after surgery and hospitalization period. It was included such as respiratory infection, length of stay in hospital, mortality, fever, admission and readmission to ICU.
- Conditions
- Nurse's Role
- Being tested
- nurse guided clinical pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse guided clinical pathwayBehavioural
Educational training sessions were provided to care providers for one week. Pre-operative; counseling and education of patient for chest physiotherapy, using spirometry, bowel preparation, early mobilization and how to predict common complications with learning to cooperate with nurses. Emphasis on patients to co-operate postoperatively was strongly stressed in spite of the pain and weakness.
Intra-operative: Optimal fluid management, short acting anesthetics, regional analgesia, opioids-sparing anesthesia, small incisions, avoiding drains, maintaining normothermia, venous thrombo-embolism [VTE] prophylaxis and antibiotic prophylaxis were routinely done.
Post-operative: Early oral nutrition, optimal fluid management, multimodal non-opioid analgesia, postoperative nausea and vomiting PONV prophylaxis, stimulation of gut motility, early removal of catheters and drains, early mobilization, chest physiotherapy and using spirometry effectively.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | All the patients admitted to surgical department during the period from early Augusts 2023until the end November 2023 matching the inclusion criteria for this study were included in the control group. The control group contained 30 patients with the same designed criteria. The control group received routine daily care of the hospital. For the control group, the two designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I and tool III] only. |
| study group | Experimental | educational training sessions were provided to care providers including the purpose and the process of implementing the pathway for one week. Following the training thee researchers started to make recruitment and screen for the study group, the researchers received consent from administration to start the data for the study group. The oral and written consent from the patient was also done, to allow the researchers to observe, make daily assessment and manage the patients according to the designed clinical pathway.
After completion of the recruitment and screening, all patients admitted to the surgical unit during the five months period from first December 2023 until the end of April 2024 were assessed and managed as study group. The study group also estimated 30 patients that met the inclusion criteria. For the study group, the three designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I, tool II and tool III] Receives: Behavioral: nurse guided clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary infection
Presence of 3 of the following: tachypnea more than 30/min, expectoration, and hypoxia, respiratory distress
Measured: 6 hours postoperatively, day 1, Day 2, and day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 May 2023
- Primary completion1 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
- Investigators
- Ayman AM Abouglala, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812182
- Sponsor's protocol ID
- Enhanced recovery clinical
- Status last verified
- Feb 2025
- First submitted
- 1 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness a Nurse Guided Enhanced Recovery Pathway on Postoperative Respiratory Tract Infection in Hepatico-Pancreatic -Biliary Surgery
- ClinicalTrials.gov ID
- NCT06812182
- Acronym / sponsor ID
- Enhanced recovery clinical
- Conditions
- Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery [ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training]. Design: Quasi-experimental study. Setting: The study was conducted in surgical department, operation unit and intensive care unit at AlRajhy liver hospital. Subjects: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group (30patient each). The control started the first then the study group. Tools: Three tools were used. Tool I: Patient assessment sheet. Tool II: Clinical pathway protocol. Tool III: Clinical outcome evaluation. The control group received tools I and III only while study group received the three tools including clinical pathway protocol [tool II].
Detailed description
: Sixty patient undergoing hepatobiliary pancreatic surgeries. The sample was divided into two groups; control and study group [30patient each]. The control started the first then the study group.
The sample size was calculated according to Epi Info 2000. A sample size was selected using a special formula based on prevalence of disease at a confidence interval of 95% and precision of (2%). The sample was increased by 10% to overcome problems related to non-responses and missing data. The power of study was 80%. Considering the following matching criteria age group, sex, diagnosis, comorbidity diseases.
The patients' inclusion criteria: Age 18-65 years old, able to communicate and Patients without vital failure [renal, hepatic, cardiac].
The patients' exclusion criteria: Past history of other organ cancer and patient refusal.
Tools:
Tool one; Patient assessment sheet:
This tool was developed by researchers based on related literature to assess the surgical patient[11]. It consisted of three parts Part1: it included socio-demographic data about the patients such as: age, gender, level of education, material status and clinical data such as patient diagnosis, past medical history, past surgical history, surgical procedure and type of anesthesia.
Part 2: Intra¬¬-operative data which included estimated blood loss, urine output, fluid and blood replacement, final balance, intraoperative complications, duration of anesthesia, duration of surgical procedure and duration of recovery.
Part 3: Post-operative assessment that included:
Physical assessment included anthropometric measurement [weight, height and body mass index] body mass index measured through dividing weight by kg on the square of height by m2, vital sign [temperature, pulse, respiration, blood pressure] Monitoring Signs of respiratory infection [cough, dyspnea, hypoxemia, tachypnea] and the need to oxygen therapy were also recorded besides monitoring arterial blood gases.
Tool two [the main research investigation] = named as clinical pathway protocol:
Clinical pathway for hepatobiliary pancreatic surgeries, this tool was developed by researchers after extensive review of related literatures and enhanced recovery after surgery pathway. The researchers used enhanced recovery after surgery to develop this tool. This tool was applied on the study group only. The six-time intervals included the three perioperative stages: the first interval represented the preoperative period, the second interval represented the intraoperative period and the next four intervals represented the postoperative period [over three days after surgery, hospitalization period]. This tool format was prepared in a matrix form that included vertical column representing applicable or not applicable and horizontal row clinical pathway items (as discussed later).
This tool consisted of three phases:
Pre-operative phase; counseling and education of patient for chest physiotherapy, using spirometry, bowel preparation, early mobilization and how to predict common complications with learning to cooperate with nurses. Emphasis on patients to co-operate postoperatively was strongly stressed in spite of the pain and weakness.
Intra-operative phrase: Optimal fluid management, short acting anesthetics, regional analgesia, opioids-sparing anesthesia, small incisions, avoiding drains, maintaining normothermia, venous thrombo-embolism [VTE] prophylaxis and antibiotic prophylaxis were routinely done.
Post-operative phase components: Early oral nutrition, optimal fluid management, multimodal non-opioid analgesia, postoperative nausea and vomiting PONV prophylaxis, stimulation of gut motility, early removal of catheters and drains, early mobilization, chest physiotherapy and using spirometry effectively.
3-Tool three: clinical outcome evaluation: This tool developed by researchers based on reviewing the recent related literature [4]. It was aimed to assess the clinical outcomes for hepatobiliary pancreatic patients three days after surgery and hospitalization period. It was included such as respiratory infection, length of stay in hospital, mortality, fever, admission and readmission to ICU.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –All the patients admitted to surgical department during the period from early Augusts 2023until the end November 2023 matching the inclusion criteria for this study were included in the control group. The control group contained 30 patients with the same designed criteria. The control group received routine daily care of the hospital. For the control group, the two designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I and tool III] only. |
| study group | Experimental | Behavioral: nurse guided clinical pathwayeducational training sessions were provided to care providers including the purpose and the process of implementing the pathway for one week. Following the training thee researchers started to make recruitment and screen for the study group, the researchers received consent from administration to start the data for the study group. The oral and written consent from the patient was also done, to allow the researchers to observe, make daily assessment and manage the patients according to the designed clinical pathway. After completion of the recruitment and screening, all patients admitted to the surgical unit during the five months period from first December 2023 until the end of April 2024 were assessed and managed as study group. The study group also estimated 30 patients that met the inclusion criteria. For the study group, the three designed study tools used to assess the patients daily and detect the clinical outcomes of the patients [tool I, tool II and tool III] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to communicate
- Patients without vital failure [renal, hepatic, cardiac].
Key exclusion criteria (2 listed)
- Past history of other organ cancer
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse guided clinical pathwayEducational training sessions were provided to care providers for one week. Pre-operative; counseling and education of patient for chest physiotherapy, using spirometry, bowel preparation, early mobilization and how to predict common complications with learning to cooperate with nurses. Emphasis on patients to co-operate postoperatively was strongly stressed in spite of the pain and weakness. Intra-operative: Optimal fluid management, short acting anesthetics, regional analgesia, opioids-sparing anesthesia, small incisions, avoiding drains, maintaining normothermia, venous thrombo-embolism [VTE] prophylaxis and antibiotic prophylaxis were routinely done. Post-operative: Early oral nutrition, optimal fluid management, multimodal non-opioid analgesia, postoperative nausea and vomiting PONV prophylaxis, stimulation of gut motility, early removal of catheters and drains, early mobilization, chest physiotherapy and using spirometry effectively. | Behavioural | study group |
Primary outcome
postoperative pulmonary infection
Time frame: 6 hours postoperatively, day 1, Day 2, and day 3
Presence of 3 of the following: tachypnea more than 30/min, expectoration, and hypoxia, respiratory distress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman AM Abouglala principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse guided clinical pathway in people with Nurse's Role, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary infection (time frame: 6 hours postoperatively, day 1, Day 2, and day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.