Clinical trial NCT06812182: Effect of Nurse Guided Enhanced Recovery Clinical Pathway on Respiratory Infection
Official title: Effectiveness a Nurse Guided Enhanced Recovery Pathway on Postoperative Respiratory Tract Infection in Hepatico-Pancreatic -Biliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: Objectives: Evaluate the effect of a nurse guided enhanced recovery pathway on postoperative respiratory tract infection in Hepatico-Pancreatic -Biliary surgery \[ pre-operative patient counselling for postoperative respiratory physiotherapy techniques and emphasis on perfect training\]. 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.

Eligibility criteria: Inclusion Criteria:

* able to communicate
* Patients without vital failure \[renal, hepatic, cardiac\].

Exclusion Criteria:

* Past history of other organ cancer
* patient refusal

Primary outcomes:
measure: postoperative pulmonary infection
timeFrame: 6 hours postoperatively, day 1, Day 2, and day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine - Assiut university
Study officials:
affiliation: Assiut University
name: Ayman AM Abouglala
role: PRINCIPAL_INVESTIGATOR
References: