Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery
Condition: Incentive Spirometry; Postoperative Pulmonary Complication; Major Abdominal Surgery
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): respiratory exercise with incentive spirometry
Intervention type(s): Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator)
Primary purpose: Prevention
Keywords: Incentive spirometry; major abdominal surgery; pulmonary complication