Major Abdominal Surgery, Incidence of Pulmonary Complications, ICOUGH Care Program.

February 12, 2024 updated by: Yeditepe University

The Effectiveness of The "I Cough" Care Program of Avoid Incidence of Pulmonary Complications Post Major Abdominal Surgery.

This study aims to determine the efficacy of a suite of interventions for reducing postoperative pulmonary complications (PPCs) after major abdominal surgery (MAS), participants were subjected to the "I COUGH" care program designed to support their health condition and reduce complications. The study aimed to investigate a simple and inexpensive pulmonary care program that can be easily understood and remembered by patients, their families, and medical staff. To achieve this goal, we chose to implement the I COUGH care program and determine the effectiveness of a range of interventions to reduce PCs after MAS.

Two hypotheses identified in the study:

H0: The ICOUGH care program reduces the incidence of PPCs after MAS. H1: The ICOUGH care program after MAS does not affect the incidence of PPCs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Surgery can result in several complications within the lungs, including respiratory infections, respiratory failure, pneumothorax, bronchospasm, pleural effusion, atelectasis, and aspiration pneumonitis. These postoperative pulmonary complications (PPCs) can make it difficult for patients to breathe and recover following surgery and can also increase the risk of death and disability.

In this study, 60 adult patients between the ages of 30 and 60 (mean 39.9; SD±8.82) (M/F: 13/47) underwent major abdominal surgery requiring general anesthesia and hospitalization, such as hernia repair, gall bladder removal, exploratory laparotomy, or other abdominal cavity procedures performed by laparoscopy or conventional laparotomy with a 5 cm or less incision above or extending above the umbilicus. The participants were randomly assigned to either the control group (n=30) or the experimental group using the block randomization method.

The Statistical Package for the Social Sciences (SPSS) version 26 Win 64 was utilized for statistical analysis. A Paired samples T-test was conducted to compare pre- and post-treatment variables, while an Independent samples T-test was carried out to examine the difference between groups. The level of significance was set at p<0.05.

The current study findings demonstrate that patients who underwent MAS were less prone to PCs after being treated with the I COUGH care program following surgery. This program comprised a flow-incentive spirometer, oral care, coughing and breathing exercises, patient, and family education, getting out of bed, and elevating the head of the bed more than 30 degrees. The results of the study revealed that I COUGH was effective in decreasing the incidence of PCs, with statistically significant differences found between the experimental and control groups (P<0.05).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Libyan Arab Jamahiriya
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • AL-ASSEMA Hospital
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • AL-KHALIL Hospital
      • Tripoli, Libyan Arab Jamahiriya, 21821
        • ROYAL Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study.
  • Eligible patients are adults of both sexes between 30-60 years (Through the study, we are trying to reduce the variance and confounding factors that may arise from including patients who are less than 30 years old due to different stages of growth, physical abilities, hormonal levels, etc., or over 60 years old due to the prevalence of chronic diseases or diseases associated with aging).
  • Patients underwent elective abdominal surgery that required general anaesthesia and hospital stay e.g., Hernia repair, gall bladder removal, exploratory laparotomy, morbid obesity, ovarian cyst, Sigmoid diverticulitis, appendicitis, or other abdominal cavity procedures performed by laparoscopy and conventional laparotomy with a 5 cm or less incision above or extending above the umbilicus. (Incisions > 5cm may affect on possible results might be impacted in terms of: Increased risk of infection, risk of bleeding, pain, and discomfort during ambulation).

Exclusion Criteria:

  • The patient complains of an unstable heart rate or cardiac condition.
  • Symptomatic heart failure, unstable angina.
  • Pulmonary Hypertension
  • Unstable hypertension
  • The patient underwent organ transplants.
  • The patient presented an aneurysm of any arterial segment.
  • Serious condition or transferred to the intensive care unit after surgery.
  • Severe nephropathy.
  • A patient with cancer.
  • Cerebrovascular accident / Stroke.
  • Patient with balance or vestibular disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The participants in the control group were evaluated on the first day after surgery and the day of discharge from clinic by using Pulse Oximetry, Sphygmometer, Spirometry Tests, VAS, MBDS and AMP. Participants in the control group were not given any information or training before or after the operation, and they were on routine hospital care.
Experimental: Experimental group
The participants in the experimental group underwent the application of several techniques to reduce pulmonary complications after major abdominal surgeries, defined by the acronym: I COUGH (Incentive spirometry, Coughing/Deep breathing, Oral care, Understanding (Education of patient and family), Getting out of bed, and raising the Head of the bed). Evaluation was conducted on the first day after surgery and the day of discharge of clinic. It was performed using Pulse Oximetry, Sphygmometer, Spirometry Tests, VAS, MBDS, AMP.
Other: I COUGH care program
I COUGH care program included a flow-incentive spirometer 10 times every 2 hours (10 efforts each set), from awake until discharge, coughing and deep breathing 3-5 times every 2 hour, and oral care at 8:00 am and 8:00 pm. including brushing teeth and rinsing with mouthwash; understanding by education of patient and family; getting out of bed to chair at least once on the day of the operation, walking at least once on the day of the operation, and out of bed to chair and walking in corridor at least three times per day, and raising the head of the bed more than 30 degrees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate (HR)
Time Frame: 3 days of postoperatively
The number of heart beats per minute.
3 days of postoperatively
Systolic Blood pressure (SBP)
Time Frame: 3 days of postoperatively
The minimum pressure recorded just prior to the next contraction.
3 days of postoperatively
Diastolic Blood pressure (DBP)
Time Frame: 3 days of postoperatively
The maximum blood pressure during contraction of the ventricles.
3 days of postoperatively
Respiratory Rate (RR)
Time Frame: 3 days of postoperatively
The number of breaths they take per minute.
3 days of postoperatively
Oxygen Saturation (SPO2)
Time Frame: 3 days of postoperatively
A pulse oximeter reading that indicates what percentage of your blood is saturated.
3 days of postoperatively
Modified Borg Dyspnea Scale (MBDS)
Time Frame: 3 days of postoperatively
A valid and reliable tool to measure the intensity of dyspnea. It is a categorical scale with ratio properties, rating from 0 to 10, 0 being not dyspneic at all and 10 being maximally dyspneic.
3 days of postoperatively
Pulmonary Function Test FVC
Time Frame: 3 days of postoperatively
Noninvasive test that show how well the lungs are working, measuring of FVC
3 days of postoperatively
Pulmonary Function Test FEV
Time Frame: 3 days of postoperatively
Noninvasive tests that show how well the lungs are working, measuring of FEV
3 days of postoperatively
Pulmonary Function Test FEV1/FVC
Time Frame: 3 days of postoperatively
3 days of postoperatively
Pulmonary Function Test PEFR
Time Frame: 3 days of postoperatively
Noninvasive tests that show how well the lungs are working, measuring of PEFR.
3 days of postoperatively
Activity and Mobility Promotion (AMP)
Time Frame: 3 days of postoperatively
AMP is based on measuring increasing patient mobility during hospital stay. The initial goals of this program included mobilization of each patient 3 times per day, documentation of patient mobility levels on the AMP scale.
3 days of postoperatively
Visual Analogue Scale (VAS)
Time Frame: 3 days of postoperatively
This measure is based on self-reported symptoms and is recorded with a single mark placed along a 10-cm line, which represents a continuum between "no pain" on the left end (0 cm) and "worst pain" on the right end. to determine the intensity of pain and its enhancement when coughing in the postoperative area.
3 days of postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Investigators

  • Principal Investigator: Feras M Tana, MSc, Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2023

Primary Completion (Actual)

January 5, 2024

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YTU.PT.TH.01/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Abdominal Surgery

Clinical Trials on I COUGH care program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe