Using Digitalized Incentive Spirometers to Assist Postoperative Rehabilitation of Abdominal Surgery Patients

• Sponsor: Taipei Medical University Shuang Ho Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06132100
• Collaborator: (none)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate; Sleep Apnea, Obstructive	Device: digitalized incentive spirometry; Device: traditional incentive spirometry	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Investigator, Outcomes Assessor)
• Masking Description: Investigator and outcomes assessor did not know the allocation of participant.
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: traditional incentive spirometry patients with traditional incentive spirometry	Device: traditional incentive spirometry; traditional incentive spirometry
Experimental: digitalized incentive spirometry patients with digitalized incentive spirometry	Device: digitalized incentive spirometry; digitalized incentive spirometry

Outcome Measures

Primary Outcome Measures

1. Apnea/Hyponea Index [7 - 10 days]

   Post operative

2. Pulse oximetry change [7 - 10 days]

   Post operative

Secondary Outcome Measures

1. Postoperative pulmonary complication [7-10 days]

   including atelectasis, pneumonia and respiratory failure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Patients undergoing bariatric surgery
• 1. Patients could cooperate with conducting incentive spirometry before and after the operation.

Exclusion Criteria:

• 1. Patients with contra-indication for incentive spirometry.
• 1. Patients could not deeply breathe with pulmonary vital capacity less than 10mL/kg.
• 1. Patients could not cooperate with conducting incentive spirometry before and after the operation.
• 1. Other causes judged by the Principal Investigator

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Taipei Medical University Shuang Ho Hospital

Investigators

• Principal Investigator: Shih-Chiang Shen, MD, Shung-Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ShihChiang Shen, Visiting staff, Taipei Medical University Shuang Ho Hospital
• ClinicalTrials.gov Identifier: NCT06132100
• Other Study ID Numbers: N202303047
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ShihChiang Shen, Visiting staff, Taipei Medical University Shuang Ho Hospital: bariatric surgery; incentive spirometry
• Additional relevant MeSH terms: Sleep Apnea, Obstructive

Study Results

No Results Posted as of Nov 15, 2023