Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery

Study Overview
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Brief Summary
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This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery. This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The investigators randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups. All study subjects were simple randomly allocated to the intervention and control groups according to the randomization table. The hypothesis of the study team was that preoperative incentive spirometry can improve the incidence of postoperative pulmonary complications in major abdominal surgery

Detailed Description
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This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The researchers randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups. The researchers included patients aged between 18 and 65 years old who underwent elective major abdominal surgery into random allocation. Patients were excluded if had a history of pulmonary disease and were unwilling or unable to take a deep breath effectively due to pain, diaphragmatic dysfunction, or opiate analgesia. All study subjects were simple randomly allocated into the intervention and control groups according to the randomization table. The intervention group (23 subjects) received respiratory exercise with incentive spirometry before surgery, and the control group (23 subjects) were given standard preoperative care. Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, The subjects were asked to inhale deeply and slowly, and were also directed to hold their breath at the end of inspiration. With alpha of 5%, beta of 10%, 39% postoperative pulmonary complication rate, as mentioned in the previous study,13 and assumption of that incentive spirometry can reduce the PPC to 30%, this study required at least 23 subjects in each group to see the effectiveness of using incentive spirometry before surgery in preventing PPC. Measures In the intervention group, pulmonary function (vital capacity [VC], vital functional capacity [VFC], and Forced expiratory volume in the first second [FEV1]) were measured three times: two times before surgery (first day before undergoing the incentive spirometry procedure and second day after using the incentive spirometry) and one time after surgery. The control group measured pulmonary function three times: two times before surgery (on the first day of admission, on the day before surgery) and one time after surgery. In addition, postoperative pulmonary function was measured up to seven days following abdominal surgery, depending on the patient's ability. On the first day after surgery, all subjects were examined by a pulmonologist, supplemented with a chest x-ray and blood gas analysis to assess the occurrence of postoperative pulmonary complications. PPC in this study included atelectasis (lung volume diminishing, caused by inadequate expansion of air cavity within lung parenchyma), pneumonia (all kinds of lung infection), and hypoxemia (ratio of PaO2: FiO2 less than 300). The researchers used means (standard deviation, SD) and numbers (percentage,%) to describe the baseline subjects demographic and clinical characteristics. Henceforth, The researchers compared the change in lung function before and after surgery between intervention and control groups. An unpaired T-test was conducted to determine if the data were normally distributed. Alternatively, the Mann-Whitney test was done for abnormally distributed data. The researchers analyzed the comparison of lung complication incidence between experimental and control groups using chi-square or Fisher's exact test method. In this study, The researchers investigated the lung function of the experimental group before and after the incentive spirometry procedure.

Official Title
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Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery In Indonesia Three Major Tertiary Hospitals: A Randomized Controlled Trial

Conditions
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Incentive Spirometry, Postoperative Pulmonary Complication, Major Abdominal Surgery

Intervention / Treatment
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* Device: respiratory exercise with incentive spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing major abdominal surgery aged between 18 and 65 years old Sign research informed consent Exclusion Criteria: Emergency surgery Have a history of lung disorders Refusing to continue incentive spirometry Patients who cannot follow instructions in using the device incentive spirometry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>The intervention group received respiratory exercise with incentive spirometry before surgery | Device: respiratory exercise with incentive spirometry<br>* Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration<br>|
| No Intervention: control group<br>The control group were given standard preoperative care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with atelectasis | The loss of lung volume is caused by inadequate expansion of the air spaces lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist | day 1 until day 7 | 
| number of participants with pneumonia | Any form of infection of the lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist | day 1 until day 7 | 
| number of participants with hypoxaemia | Hypoxaemia was defined as PaO2/FiO2 <300 as assessed by blood gas analysis | day 1 until day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity | It is the total amount of air exhaled after maximal inhalation | Preoperative, day 1 before surgery, and until day 7 after surgery | 
| forced vital capacity | the maximum amount of air you can forcibly exhale from your lungs after fully inhaling | Preoperative, day 1 before surgery, and until day 7 after surgery | 
| Forced expiratory volume in the first second | the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration | Preoperative, day 1 before surgery, and until day 7 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incentive spirometry, major abdominal surgery, pulmonary complication