Bariatric Surgery CandidateNCT06132100
Using Digitalized Incentive Spirometers to Assist Postoperative Rehabilitation of Abdominal Surgery Patients
A study testing digitalized incentive spirometry and traditional incentive spirometry in people with Bariatric Surgery Candidate and Sleep Apnea, Obstructive, run by Taipei Medical University Shuang Ho Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Bariatric Surgery Candidate, Sleep Apnea, Obstructive
- What is being tested?
- digitalized incentive spirometry and traditional incentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients undergoing bariatric surgery
- 2. Patients could cooperate with conducting incentive spirometry before and after the operation.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- digitalized incentive spirometry, traditional incentive spirometry
- Keywords
- bariatric surgery, incentive spirometry
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digitalized incentive spirometryDevice
digitalized incentive spirometry
traditional incentive spirometryDevice
traditional incentive spirometry
| Study group | Role | What they receive |
|---|---|---|
| traditional incentive spirometry | Placebo comparator | patients with traditional incentive spirometry Receives: Device: traditional incentive spirometry |
| digitalized incentive spirometry | Experimental | patients with digitalized incentive spirometry Receives: Device: digitalized incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hyponea Index
Post operative
Measured: 7 - 10 days
Pulse oximetry change
Post operative
Measured: 7 - 10 days
Secondary outcomes (1)
Postoperative pulmonary complication
including atelectasis, pneumonia and respiratory failure
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShihChiang Shen, Taipei Medical University Shuang Ho Hospital
- Investigators
- Shih-Chiang Shen, MD, Principal investigator, Shung-Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132100
- Sponsor's protocol ID
- N202303047
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06132100
- Acronym / sponsor ID
- N202303047
- Keywords
- bariatric surgery, incentive spirometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| traditional incentive spirometry | Placebo comparator | Device: traditional incentive spirometrypatients with traditional incentive spirometry |
| digitalized incentive spirometry | Experimental | Device: digitalized incentive spirometrypatients with digitalized incentive spirometry |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients undergoing bariatric surgery
- 2. Patients could cooperate with conducting incentive spirometry before and after the operation.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digitalized incentive spirometrydigitalized incentive spirometry | Device | digitalized incentive spirometry |
| traditional incentive spirometrytraditional incentive spirometry | Device | traditional incentive spirometry |
Primary outcome
Apnea/Hyponea Index
Time frame: 7 - 10 days
Post operative
Pulse oximetry change
Time frame: 7 - 10 days
Post operative
1 secondary outcome
Postoperative pulmonary complication
Time frame: 7-10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shih-Chiang Shen, MD principal investigator
Shung-Ho Hospital
Questions about this trial
What is this clinical trial studying?
A study testing digitalized incentive spirometry and traditional incentive spirometry in people with Bariatric Surgery Candidate and Sleep Apnea, Obstructive, run by Taipei Medical University Shuang Ho Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chiang Shen, MD (886-2-22490088 ext. 8123, shsich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/Hyponea Index (time frame: 7 - 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.