Craniocerebral TumorsNCT07571759
Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors
A study testing intervention group in people with Craniocerebral Tumors, run by The Affiliated Brain Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Title of Study: A New Nursing System to Help Lung Recovery After Brain Tumor Surgery Why was this study done? After surgery for a brain tumor (craniocerebral tumor), some patients develop lung problems like pneumonia or collapsed lung areas (atelectasis). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniocerebral Tumors
- What is being tested?
- intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, inclusive
- Preoperative diagnosis of intracranial tumor confirmed by imaging and/or pathology per WHO Classification of Tumours of the Central Nervous System (5th edition), with planned craniotomy for tumor resection (initial or recurrent surgery)
- Preoperative assessment confirms ability to cooperate with pulmonary rehabilitation training (adequate consciousness, cognition, and communication for short-term training)
- Voluntary participation with written informed consent
Who cannot join
- Pre-existing severe chronic obstructive pulmonary disease (COPD GOLD stages 3-4)
- Pre-existing severe interstitial lung disease
- Requirement for long-term oxygen therapy
- Pneumonia or respiratory failure requiring mechanical ventilation within one month prior to surgery
- Severe cardiac dysfunction (New York Heart Association class III-IV)
- Other major organ insufficiency
Show all 11Show fewer
- Severe impairment of consciousness
- Inability to follow commands
- Language barriers
- Life expectancy less than 30 days
- Concurrent participation in other interventional studies that could confound pulmonary function outcomes
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Title of Study:
A New Nursing System to Help Lung Recovery After Brain Tumor Surgery
Read more
Why was this study done? After surgery for a brain tumor (craniocerebral tumor), some patients develop lung problems like pneumonia or collapsed lung areas (atelectasis). These problems can slow down recovery, keep patients in the hospital longer, and make them feel worse. Doctors and nurses wanted to find a better way to protect the lungs and help patients breathe easier after surgery.
What did the researchers want to find out? They wanted to see if a special, step-by-step nursing system for lung recovery-called the Perioperative Pulmonary Rehabilitation Nursing System (PPRNS) -could reduce lung problems after brain tumor surgery and help patients get back on their feet faster.
What was done in the study?
Who: 165 patients having brain tumor surgery at one hospital.
How: Patients were put into two groups by chance (like flipping a coin):
Control group (81 patients): Received regular, standard care after surgery.
Intervention group (84 patients): Received the new PPRNS care. This included:
Before surgery: Breathing exercises, learning to cough effectively, and nutrition advice.
During surgery: Lung-protective methods by the anesthesia team.
After surgery: Deep breathing exercises, sitting up and moving early, help clearing mucus from the lungs, and close monitoring.
What was measured: The main thing measured was how many patients developed lung problems (like pneumonia) within 14 days after surgery. They also checked lung function, how fast patients recovered (walking, eating, removing tubes), length of hospital stay, and patient satisfaction.
What were the main results?
Fewer lung problems: Only 4.8% of patients in the new care group developed lung complications, compared to 13.6% in the regular care group. This means the new system cut lung problems by more than half.
Better breathing: Patients in the new care group had stronger lung function tests (FVC, PEF) and higher oxygen levels after surgery.
Faster recovery: They got off breathing tubes earlier, started walking sooner, cou
- Conditions
- Craniocerebral Tumors
- Being tested
- intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupBehavioural
The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Not described Receives: Behavioral: intervention group |
| The control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Pulmonary Complications (PPCs)
Description: The occurrence of respiratory system-related complications, including but not limited to:
Pneumonia (diagnosed based on clinical symptoms, laboratory findings, and radiographic evidence: fever, purulent sputum, pulmonary rales, new infiltrates on chest X-ray or CT)
Atelectasis (confirmed radiographically)
Severe hypoxemia requiring intervention
Airway spasm
Aspiration
Measured: Within 14 days post-surgery
Secondary outcomes (13)
Forced Vital Capacity (FVC)
Assessed via portable spirometry. Expressed in liters (L).
Measured: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Recovery Metrics (Functional Recovery Indicators)
Surgery end through extubation, assessed up to 72 hours Surgery end through first effective cough, assessed up to 7 days Surgery end through first standing/walking, assessed up to 14 days Surgery end through catheter removal, assessed up to 14 days Surgery end through first oral intake, assessed up to 14 days
Measured: From surgery end until achievement (measured in hours or days)
Postoperative Length of Hospital Stay
Time from surgery date to hospital discharge meeting clinical criteria. Measured in days.
Measured: At hospital discharge, assessed through study completion (average of 14 days)
Incidence of Other (Non-Pulmonary) Complications
Intracranial hematoma
Worsened cerebral edema
Neurological deterioration
Deep vein thrombosis (DVT)
Surgical site infection
Measured: Within 14 days post-surgery
Postoperative Length of Hospital Stay
Time from surgery date to hospital discharge meeting clinical criteria. Measured in days.
Measured: At hospital discharge, assessed through study completion (average of 14 days post-surgery)
Patient Satisfaction with Nursing Care
Patient satisfaction with perioperative nursing care measured using a 100-point satisfaction scale (0 to 100 points). Higher scores indicate greater satisfaction (better outcome). Note: This is a non-validated satisfaction scale designed for this study.
Measured: At hospital discharge (average of 14 days post-surgery)
Peak Expiratory Flow (PEF)
Measured by a peak flow meter. Expressed in liters per minute (L/min).
Measured: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Peripheral Oxygen Saturation (SpO₂)
Measured at rest on room air. Expressed as percentage (%).
Measured: Preoperative, postoperative day 1, and postoperative day 3
Barthel Index Score
Barthel Index assesses functional independence in activities of daily living. Total score ranges from 0 to 100. Higher scores indicate better functional independence (better outcome).
Measured: At hospital discharge (average of 14 days post-surgery)
36-Item Short Form Health Survey (SF-36) Total Score
SF-36 assesses health-related quality of life. Total score ranges from 0 to 100. Higher scores indicate better quality of life (better outcome).
Measured: At hospital discharge (average of 14 days post-surgery)
Forced Vital Capacity (FVC)
Assessed via portable spirometry. Measured in liters (L).
Measured: Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
Time to First Ambulation
Time from surgery end to first standing or walking with or without assistance. Measured in hours.
Measured: From surgery end to first ambulation, assessed up to 14 days post-surgery
Time to First Effective Autonomous Cough
Time from surgery end to first effective cough performed independently by the patient (able to clear secretions). Measured in hours.
Measured: From surgery end to first effective cough, assessed up to 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start5 Feb 2025
- Primary completion7 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniocerebral TumorsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Brain Hospital of Nanjing Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Haiyan Qiu, The Affiliated Brain Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571759
- Sponsor's protocol ID
- No. 2026-KY030-01
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors
- ClinicalTrials.gov ID
- NCT07571759
- Acronym / sponsor ID
- No. 2026-KY030-01
- Conditions
- Craniocerebral Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The Affiliated Brain Hospital of Nanjing Medical UniversityOther government
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 7 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 6 May 2026 (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.
Title of Study:
A New Nursing System to Help Lung Recovery After Brain Tumor Surgery
Why was this study done? After surgery for a brain tumor (craniocerebral tumor), some patients develop lung problems like pneumonia or collapsed lung areas (atelectasis). These problems can slow down recovery, keep patients in the hospital longer, and make them feel worse. Doctors and nurses wanted to find a better way to protect the lungs and help patients breathe easier after surgery.
What did the researchers want to find out? They wanted to see if a special, step-by-step nursing system for lung recovery-called the Perioperative Pulmonary Rehabilitation Nursing System (PPRNS) -could reduce lung problems after brain tumor surgery and help patients get back on their feet faster.
What was done in the study?
Who: 165 patients having brain tumor surgery at one hospital.
How: Patients were put into two groups by chance (like flipping a coin):
Control group (81 patients): Received regular, standard care after surgery.
Intervention group (84 patients): Received the new PPRNS care. This included:
Before surgery: Breathing exercises, learning to cough effectively, and nutrition advice.
During surgery: Lung-protective methods by the anesthesia team.
After surgery: Deep breathing exercises, sitting up and moving early, help clearing mucus from the lungs, and close monitoring.
What was measured: The main thing measured was how many patients developed lung problems (like pneumonia) within 14 days after surgery. They also checked lung function, how fast patients recovered (walking, eating, removing tubes), length of hospital stay, and patient satisfaction.
What were the main results?
Fewer lung problems: Only 4.8% of patients in the new care group developed lung complications, compared to 13.6% in the regular care group. This means the new system cut lung problems by more than half.
Better breathing: Patients in the new care group had stronger lung function tests (FVC, PEF) and higher oxygen levels after surgery.
Faster recovery: They got off breathing tubes earlier, started walking sooner, cou
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: intervention group |
| The control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years, inclusive
- Preoperative diagnosis of intracranial tumor confirmed by imaging and/or pathology per WHO Classification of Tumours of the Central Nervous System (5th edition), with planned craniotomy for tumor resection (initial or recurrent surgery)
- Preoperative assessment confirms ability to cooperate with pulmonary rehabilitation training (adequate consciousness, cognition, and communication for short-term training)
- Voluntary participation with written informed consent
Key exclusion criteria (11 listed)
- Pre-existing severe chronic obstructive pulmonary disease (COPD GOLD stages 3-4)
- Pre-existing severe interstitial lung disease
- Requirement for long-term oxygen therapy
- Pneumonia or respiratory failure requiring mechanical ventilation within one month prior to surgery
- Severe cardiac dysfunction (New York Heart Association class III-IV)
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 |
|---|---|---|
| intervention groupThe intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care. | Behavioural | The intervention group |
Primary outcome
Incidence of Postoperative Pulmonary Complications (PPCs)
Time frame: Within 14 days post-surgery
Description: The occurrence of respiratory system-related complications, including but not limited to: Pneumonia (diagnosed based on clinical symptoms, laboratory findings, and radiographic evidence: fever, purulent sputum, pulmonary rales, new infiltrates on chest X-ray or CT) Atelectasis (confirmed radiographically) Severe hypoxemia requiring intervention Airway spasm Aspiration
13 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Recovery Metrics (Functional Recovery Indicators)
Time frame: From surgery end until achievement (measured in hours or days)
Postoperative Length of Hospital Stay
Time frame: At hospital discharge, assessed through study completion (average of 14 days)
Incidence of Other (Non-Pulmonary) Complications
Time frame: Within 14 days post-surgery
Postoperative Length of Hospital Stay
Time frame: At hospital discharge, assessed through study completion (average of 14 days post-surgery)
Patient Satisfaction with Nursing Care
Time frame: At hospital discharge (average of 14 days post-surgery)
Peak Expiratory Flow (PEF)
Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Peripheral Oxygen Saturation (SpO₂)
Time frame: Preoperative, postoperative day 1, and postoperative day 3
Barthel Index Score
Time frame: At hospital discharge (average of 14 days post-surgery)
36-Item Short Form Health Survey (SF-36) Total Score
Time frame: At hospital discharge (average of 14 days post-surgery)
Forced Vital Capacity (FVC)
Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
Time to First Ambulation
Time frame: From surgery end to first ambulation, assessed up to 14 days post-surgery
Time to First Effective Autonomous Cough
Time frame: From surgery end to first effective cough, assessed up to 7 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Craniocerebral Tumors, run by The Affiliated Brain Hospital of Nanjing Medical University at 1 site in China.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pulmonary Complications (PPCs) (time frame: Within 14 days post-surgery). 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 6 May 2026.