Using Digitalized Incentive Spirometers to Assist Postoperative Rehabilitation of Abdominal Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: digitalized incentive spirometry, traditional incentive spirometry.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Sleep Apnea, Obstructive. Basic parameters: 20 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Wireless Transformation of Portable Three-ball Incentive Spirometers to Assist the Record of Postoperative Rehabilitation and Pulmonary Function Change in Patients Undergoing Abdominal Surgery
Overview
The purpose of this clinical trial is to use a digital recording device integrated with an incentive spirometer to record a patient's deep breathing lung training following abdominal surgery. Through this digital recording, it will be possible to effectively assess the daily frequency, duration, depth of deep breaths, and the volume of inhalation performed by the patient during their breathing exercises. This will transform the previously difficult-to-describe deep breathing training into a digital record, allowing healthcare professionals to quickly evaluate the patient's condition. Patients can also monitor their own respiratory function changes, leading to positive health promotion benefits, accelerating their postoperative recovery, and simultaneously reducing healthcare costs and improving medical quality.
Detailed description
After thoracoabdominal and neurosurgery procedures, an incentive spirometer is commonly employed for deep breathing exercises to prevent or improve potential postoperative pulmonary atelectasis, increase lung capacity, promote the clearance of respiratory secretions, and maintain chest mobility to reduce postoperative complications related to lung collapse. This medical device and the respiratory training process are essential components of Enhanced Recovery After Surgery (ERAS) protocols, which integrate postoperative care processes to enhance recovery, reduce hospitalization times, and minimize postoperative complications. Currently, clinical guidelines typically recommend patients to perform 200-600 deep inhalations per day after surgery. Despite the simplicity and effectiveness of using an incentive spirometer for deep breathing exercises, the observation of patients' usage, recording of the number and duration of exercises, and tracking of their deep inhalation volumes have become crucial tasks for respiratory therapists, nurses, and physicians in the postoperative setting, consuming significant time and resources.
Generally, using an incentive spirometer requires patients to perform 200-600 deep breaths a day. According to a 2018 medical literature estimate in the United States, approximately 9.7 million surgical procedures annually involve the use of incentive spirometers, with human resource costs for assisting patients in their use and assessing the effectiveness of their pulmonary rehabilitation reaching approximately one billion US dollars.
Interventions
- Device digitalized incentive spirometry
digitalized incentive spirometry - Device traditional incentive spirometry
traditional incentive spirometry
Primary outcome measures
- Apnea/Hyponea Index [Time frame: 7 - 10 days]
- Pulse oximetry change [Time frame: 7 - 10 days]
Secondary outcome measures (1)
- Postoperative pulmonary complication [Time frame: 7-10 days]
Eligibility criteria
Inclusion criteria
- 1\. Patients undergoing bariatric surgery
- 2\. Patients could cooperate with conducting incentive spirometry before and after the operation.
Exclusion criteria
- 1\. Patients with contra-indication for incentive spirometry.
- 2\. Patients could not deeply breathe with pulmonary vital capacity less than 10mL/kg.
- 3\. Patients could not cooperate with conducting incentive spirometry before and after the operation.
- 4\. Other causes judged by the Principal Investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06132100 · N202303047