Acupressure combined with a flexible pressure sensor to treat coughing in patients undergoing bronchoalveolar lavage
| ISRCTN | ISRCTN18030444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18030444 |
- Submission date
- 21/10/2024
- Registration date
- 25/10/2024
- Last edited
- 25/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The study focuses on improving the quality of anesthesia recovery in patients undergoing bronchoalveolar lavage (BAL) using flexible bronchoscopy. Traditional recovery methods often involve routine monitoring, but this study explores the potential benefits of combining acupressure with flexible pressure sensor manometry. The primary aim is to investigate whether acupressure, when combined with flexible pressure sensor manometry, can enhance the recovery process post-anesthesia. Specifically, the study examines the impact on postoperative cough frequency, length of stay in the post-anesthesia care unit (PACU), incidence of stress urinary incontinence, and heart rate during the recovery period.
Who can participate?
Adult patients aged 18-64 years old who underwent BALusing flexible bronchoscopy at the First Affiliated Hospital of Zhengzhou University.
What does the study involve?
The patients were randomly divided into two groups: the acupressure group (Group A) and the control group (Group C). After the operation, all patients were transferred to the post-anesthesia care unit (PACU). In Group A, acupressure was applied to specific points (Tiantu [RN22], Chize [LU5], and Taiyuan [LU9]) after the removal of the laryngeal mask. The pressure and duration of the acupressure were measured using flexible pressure sensors. In contrast, Group C received routine PACU monitoring without acupressure.
During the recovery period in the PACU, several parameters were observed and analyzed, including:
Postoperative cough frequency (number of coughs)
Length of stay in PACU
Occurrence of stress urinary incontinence
Heart rate (HR)
These observations aimed to assess the effectiveness of acupressure combined with flexible pressure sensor manometry in improving the quality of anesthesia recovery.
What are the possible benefits and risks of participating?
Benefits: Reduces postoperative cough;Painless treatment of cough
Risks: Local skin redness phenomenon
Where is the study run from?
Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital of Zhengzhou University, China.
When is the study starting and how long is it expected to run for?
November 2023 to May 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Lijun Jia, fccjialj@zzu.edu.cn
Contact information
Public, Scientific, Principal Investigator
Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital of Zhengzhou University
Zhengzhou
450002
China
 ORCID ID |
0000-0002-4650-666X |
|---|---|
| Phone | +8618737197159 |
| fccjialj@zzu.edu.cn |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school, Workplace |
| Study type | Prevention, Treatment, Safety, Efficacy |
| Scientific title | Effect of acupressure combined with flexible pressure sensor manometry on the quality of anesthesia recovery in patients undergoing bronchoalveolar lavage-A randomized controlled trial |
| Study acronym | BAL |
| Study objectives | Acupressure combined with flexible pressure sensor manometry improves the quality of anesthesia recovery |
| Ethics approval(s) |
Approved 26/12/2023, Research and Clinical Trial Ethics Committee of the First Affiliated Hospital of Zhengzhou University (First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China; +86 13783593652; 13783593652@163.com), ref: 2023-KY-0912-003 |
| Health condition(s) or problem(s) studied | Acupressure combined with flexible pressure sensor manometry to improve the quality of anesthesia recovery |
| Intervention | This study is a two-group parallel randomized trial. All the patients were divided into two groups (1:1): the acupressure group (group A) and the control group (group C) using the random number table method. Group A acupressure method: The patient was asked to inhale, with the thumb acupoint pressed for 2.0s to reach the peak, and the pressure gradually decreased (0~3.5s), and each acupoint was pressed for 3 min. All three acupoints were pressed using the same method. The total intervention time was 30 min. The pressure of acupuncture points (N) was observed and the time of acupoint pressure was recorded (s). Group C was not given acupressure after surgery, and the rest of the post-anesthesia care unit (PACU) care was the same as group A's. Follow-up for both study arms: During the recovery period of anesthesia: PACU dwell time; Mean cough during the recovery period from anesthesia (times/min); Mean pulse during anesthesia recovery (times/min); Mild Cough; Severe cough; HR (>100 times/min); BP (>140mmHg); Stress Urinary Incontinence (Female) After 6 hours: Cough with bloody sputum; the throat is swollen and sore |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Cough Grading: The intensity and duration of coughing were recorded. According to the outbreak phase of the cough, a series of coughs in each time course is recorded as 1 cough, and the intensity of the cough is divided into three levels: mild (1~2 times/min), moderate (3~4 times/min), and severe (>5 times/min). The evaluation was done immediately after extubation, 30 minutes after removal of the laryngeal mask, and on the transfer out of the PACU. |
| Secondary outcome measures | The following secondary outcome measures data were collected throughout the procedure: 1. Duration of anesthesia 2. Remifentanil dosage 3. Micuronium chloride dose 4. Betamethasone dose 5. Duration of surgery 6. Endotracheal lavage 7. Endotracheal lavage recovery fluid |
| Overall study start date | 01/11/2023 |
| Completion date | 30/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 163 |
| Total final enrolment | 132 |
| Key inclusion criteria | 1. Age between 18-64 years old 2. ASA Class I or II 3. No cough or mild cough |
| Key exclusion criteria | 1. Skin lesions around Tiantu (RN22), Chize (LU5), and Taiyuan (LU9) points 2. Recent massive hemoptysis 3. Diffuse alveolar hemorrhage 4. Untreated active tuberculosis 5. Obvious electrolyte imbalance 6. Inability to understand communication-related trials or informed consent |
| Date of first enrolment | 26/12/2023 |
| Date of final enrolment | 30/05/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Zhengzhou
450002
China
Sponsor information
Hospital/treatment centre
Department of Anesthesiology and Perioperative Medicine, No. 1 Jianshe East Road
Zhengzhou
450002
China
| Phone | +86 13783593652 |
|---|---|
| 13783593652@163.com | |
| Website | http://fcc.zzu.edu.cn/ |
"ROR" |
https://ror.org/056swr059 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Other non-profit organizations
- Alternative name(s)
- The First Affiliated Hospital of Zhengzhou University, 郑州大学第一附属医院
- Location
- China
Results and Publications
| Intention to publish date | 25/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal; BMC Anesthesiology |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Lijun Jia, fccjialj@zzu.edu.cn, after publication. |
Editorial Notes
22/10/2024: Study's existence confirmed by the Research and Clinical Trial Ethics Committee of the First Affiliated Hospital of Zhengzhou University.
