Perioperative respiratory therapy hierarchical management in enhanced recovery after surgery
| ISRCTN | ISRCTN18425201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18425201 |
| Secondary identifying numbers | 2022021530 |
- Submission date
- 12/05/2025
- Registration date
- 16/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study focuses on improving recovery after surgery, especially for patients having chest or upper abdominal operations. After surgery, some patients develop breathing problems like lung infections or difficulty getting enough oxygen, which can slow recovery and increase hospital stays. The study tests a new approach called "graded respiratory care management," which includes breathing exercises before surgery, special lung-protecting techniques during surgery and guided breathing exercises after surgery. This study aims to see if this approach helps patients recover faster, reduces breathing problems, and shortens hospital stays.
Who can participate?
Adults (18 years or older) scheduled for chest or upper abdominal surgery can join.
What does the study involve?
Participants are randomly divided into two groups:
1. Standard care group: Receives usual medical treatment.
2. Graded respiratory care group: Receives extra breathing exercises before surgery, lung-protecting techniques during surgery, and guided exercises after surgery.
Doctors will check lung function (using simple breathing tests), blood oxygen levels, and track recovery progress.
What are the possible benefits and risks of participating?
Possible benefits:
- Better lung recovery after surgery.
- Lower chance of breathing problems.
- Possibly shorter hospital stay.
Possible risks:
- Breathing exercises may feel tiring.
- Minor discomfort from tests (e.g., blood draws).
- No extra physical harm—all methods are safe and proven.
Where is the study run from?
The Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, China
When is the study starting and how long is it expected to run for?
January 2022 to June 2025
Who is funding the study?
This study receives no external funding.
Who is the main contact?
Dr. Ge Huiqing, Gehq@zju.edu.cn
Contact information
Principal Investigator
Sir Run Run Shaw Hospital
3 East Qinchun Rd
Hangzhou
310016
China
 ORCID ID |
0000-0002-5822-2998 |
|---|---|
| Phone | +86 13588706787 |
| gehq@zju.edu.cn |
Scientific
Sir Run Run Shaw Hospital
3 East Qinchun Rd
Hangzhou
310016
China
| ORCID ID |
0000-0002-4730-9633 |
|---|---|
| Phone | +86 13634115344 |
| xuyiqing@srrsh.com |
Public
Sir Run Run Shaw Hospital
3 East Qinchun Rd
Hangzhou
310016
China
| Phone | +86 19883130216 |
|---|---|
| 2259784284@qq.com |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact detail to request a participant information sheet. |
| Scientific title | Respiratory stratification for periorperative optimization in enhanced recovery after surgery: a multicenter study |
| Study acronym | RESPRO-ERAS |
| Study objectives | Graded perioperative respiratory management reduces length of stay |
| Ethics approval(s) |
Approved 15/02/2022, Ethics Committee of Sir Run Run Shaw Hospital Zhejiang University School of Medicine (3 East Qinchun Rd, Sir Run Run Shaw Hospital, Hangzhou, 310016, China; +86 571 86006811; 594961420@qq.com), ref: 20250323 |
| Health condition(s) or problem(s) studied | Recovery after surgery |
| Intervention | Participants are randomized using a simple randomization method at the time of recruitment into an intervention group and a control group. Four aspects of the patient's condition were assessed: aerosol therapy, bronchial hygiene, lung expansion, and aerobic exercise. -Control Group Guided deep breathing exercises, to achieve the pre-operative assessment's FVC (forced vital capacity) -Experimental Group 1. Aerosol Therapy （AT） Score 0-2: Continue previous treatment Score 3-4: Bronchodilator inhalation (Salbutamol 2.5 mg, three times daily) Score 5-6: Bronchodilator inhalation (Salbutamol 2.5 mg + Ipratropium Bromide 0.5 mg, three times daily) Score >7: Bronchodilator inhalation (Salbutamol 2.5 mg + Ipratropium Bromide 0.5 mg, three times daily) + combination therapy, three times daily 2. Bronchial Hygiene (BH) Score 0-2: Deep breathing, 3-5 times per hour Score 3-4: Coughing guidance 3-5 times per hour + Flutter 3-5 times per hour for 6-8 hours Score 5-6: Metaneb or High Frequency Chest Wall Oscillation twice daily Score >7: Same as 5-6, with possible bronchoscopy if necessary 3. Lung Expansion (LE) Score 3-4: Inhalation device (IS) 5-10 times per hour for 6-8 hours Score >5: If ineffective, PEP (Positive Expiratory Pressure) with a three-ball resistance device, set to maximum resistance FVC < 15 ml/kg: Non-invasive ventilation 12/6 cmH2O for 2 hours twice daily 4. Aerobic Exercise (AE) Daily walking distance and time: 6-minute walk distance / 6 * 20 minutes * 0.8 meter |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Length of stay measured using data collected from the hospital record at one time point |
| Secondary outcome measures | Maximum Inspiratory Pressure and Forced Vital Capacity, measured using pulmonary function testing, post-operatively at day 2 |
| Overall study start date | 01/01/2022 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Peri-operative patient 2. Age over 18 years old |
| Key exclusion criteria | 1. Age less than 18 years old 2. Pregnant 3. Neuromuscular disease 4. Other systemic diseases induced ineligibility for surgery 5. Impaired cognitive functions 6.Refuse to enroll |
| Date of first enrolment | 15/02/2022 |
| Date of final enrolment | 05/06/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Hangzhou
310016
China
Yongkang
321399
China
Shaoxing
312035
China
Jinhua
321299
China
Zhoushan
316199
China
Lanxi
321102
China
Jiaxing
314001
China
Ningbo
315192
China
Wenzhou
325000
China
Ningbo
315010
China
Linhai
318000
China
Sponsor information
Hospital/treatment centre
3 East Qinchun Rd
Hangzhou
310016
China
| Phone | +86 0571-86090073 |
|---|---|
| srrsh@zju.edu.cn | |
| Website | http://www.srrsh.com/ |
"ROR" |
https://ror.org/00ka6rp58 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Editorial Notes
27/05/2025: The following changes were made to the trial record:
1. The scientific title was changed from "Graded perioperative respiratory management in enhanced recovery after surgery: a multicenter study" to "Respiratory stratification for periorperative optimization in enhanced recovery after surgery: a multicenter study".
2. The acronym was changed from GRAM-ERAS to RESPRO-ERAS.
12/05/2025: Study's existence confirmed by the Ethics Committee Approval Letter of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
