SputumNCT06508008
Rapid and Safe Sputum Suction Method Validation
A study testing continuous negative pressure suction and Intermittent negative pressure sputum suction through oral pharyngeal airway in people with Sputum, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Sputum
- What is being tested?
- continuous negative pressure suction and Intermittent negative pressure sputum suction through oral pharyngeal airway
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 18 Aug 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical diagnosis of stroke; 2. Clinical diagnosis of comatose;
Who cannot join
- 1. Clinical diagnosis of multiple organ failure; 2. Clinical diagnosis of multiple organ bleeding;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Honglei Wu, MS, +8613862749927, wu_honglei@163.com
MS
About this study
Official title: Verification of the Effect of Intermittent Negative Pressure Sputum Suction Through Oral Pharyngeal Ventilation Tube in Comatose Patients
600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction.
Read the detailed description
Research content: (1) Selection and placement methods of oropharyngeal ventilation tubes, studying the application effects of different models and sizes of oropharyngeal ventilation tubes in critically ill patients, exploring the best placement method to improve the efficiency and safety of sputum suction operations. (2) The norms and techniques of sputum suction, the steps, techniques, and precautions of sputum suction, the depth, strength, time of insertion, and when to interrupt negative pressure, in order to minimize damage to the patient's respiratory mucosa. (3) Evaluation of patient comfort and tolerance, assessing the tolerance and potential adverse reactions of critically ill patients during oral pharyngeal intubation for sputum suction, providing a basis for optimizing sputum suction. (4) Evaluation of sputum suction effect, comparing blood oxygen saturation, respiratory distress, sputum sounds, and other indicators before and after sputum suction to evaluate the effectiveness of sputum suction.
- Conditions
- Sputum
- Being tested
- continuous negative pressure suction, Intermittent negative pressure sputum suction through oral pharyngeal airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous negative pressure suctionProcedure or surgery
(1) Open the mouth with a tongue depressor; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) Insert a suction tube into the mouth to aspirate phlegm.
Intermittent negative pressure sputum suction through oral pharyngeal airwayProcedure or surgery
(1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum
| Study group | Role | What they receive |
|---|---|---|
| Intermittent negative pressure sputum suction through oral pharyngeal airway | Experimental | (1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum Receives: Procedure: continuous negative pressure suction; Procedure: Intermittent negative pressure sputum suction through oral pharyngeal airway |
| continuous negative pressure suction | No intervention | (1) Use a tongue depressor to open the mouth; (2) Lubricating the front end of the sputum suction tube with paraffin oil; (3) Insert a suction tube into the oral cavity to aspirate phlegm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen saturation before and after sputum aspiration
The degree of binding between oxygen and hemoglobin (Hb) in arterial blood
Measured: Not exceeding 1 day
Suctioning time
All time required for sputum suction process
Measured: Not exceeding 2 minute
Degree of airway bleeding
Use a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light.
Measured: Not exceeding 30 minute
Secondary outcomes (1)
Patient family satisfaction
After suctioning, use a satisfaction questionnaire to survey the operating nurses, with a minimum score of 1 and a maximum score of 5. The higher the value, the higher the satisfaction.
Measured: Not exceeding 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start18 Feb 2024
- Primary completion9 Jul 2024
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SputumStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, MD, Study chair, Ethics Committee of Nantong University Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508008
- Sponsor's protocol ID
- 2024-K119-01
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Effect of Intermittent Negative Pressure Sputum Suction Through Oral Pharyngeal Ventilation Tube in Comatose Patients
- ClinicalTrials.gov ID
- NCT06508008
- Acronym / sponsor ID
- 2024-K119-01
- Conditions
- Sputum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 18 Jul 2024 (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.
600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction.
Detailed description
Research content: (1) Selection and placement methods of oropharyngeal ventilation tubes, studying the application effects of different models and sizes of oropharyngeal ventilation tubes in critically ill patients, exploring the best placement method to improve the efficiency and safety of sputum suction operations. (2) The norms and techniques of sputum suction, the steps, techniques, and precautions of sputum suction, the depth, strength, time of insertion, and when to interrupt negative pressure, in order to minimize damage to the patient's respiratory mucosa. (3) Evaluation of patient comfort and tolerance, assessing the tolerance and potential adverse reactions of critically ill patients during oral pharyngeal intubation for sputum suction, providing a basis for optimizing sputum suction. (4) Evaluation of sputum suction effect, comparing blood oxygen saturation, respiratory distress, sputum sounds, and other indicators before and after sputum suction to evaluate the effectiveness of sputum suction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent negative pressure sputum suction through oral pharyngeal airway | Experimental | Procedure: continuous negative pressure suction, Procedure: Intermittent negative pressure sputum suction through oral pharyngeal airway(1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum |
| continuous negative pressure suction | No intervention | –(1) Use a tongue depressor to open the mouth; (2) Lubricating the front end of the sputum suction tube with paraffin oil; (3) Insert a suction tube into the oral cavity to aspirate phlegm. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Clinical diagnosis of stroke; 2. Clinical diagnosis of comatose;
Key exclusion criteria (1 listed)
- 1. Clinical diagnosis of multiple organ failure; 2. Clinical diagnosis of multiple organ bleeding;
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 |
|---|---|---|
| continuous negative pressure suction(1) Open the mouth with a tongue depressor; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) Insert a suction tube into the mouth to aspirate phlegm. | Procedure or surgery | Intermittent negative pressure sputum suction through oral pharyngeal airway |
| Intermittent negative pressure sputum suction through oral pharyngeal airway(1) Insert the oropharyngeal airway parallel into the oral cavity; (2) Apply paraffin oil to the front end of the sputum suction tube; (3) The suction tube is inserted into the deep oral cavity through the middle lumen of the oropharyngeal airway; (4) Intermittent negative pressure for suction and suction of sputum | Procedure or surgery | Intermittent negative pressure sputum suction through oral pharyngeal airway |
Primary outcome
Blood oxygen saturation before and after sputum aspiration
Time frame: Not exceeding 1 day
The degree of binding between oxygen and hemoglobin (Hb) in arterial blood
Suctioning time
Time frame: Not exceeding 2 minute
All time required for sputum suction process
Degree of airway bleeding
Time frame: Not exceeding 30 minute
Use a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light.
1 secondary outcome
Patient family satisfaction
Time frame: Not exceeding 1 day
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 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Sputum
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.
Tao Zhang, MD study chair
Ethics Committee of Nantong University Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous negative pressure suction and Intermittent negative pressure sputum suction through oral pharyngeal airway in people with Sputum, run by Affiliated Hospital of Nantong 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Aug 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?
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 Honglei Wu, MS (+8613862749927, wu_honglei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen saturation before and after sputum aspiration (time frame: Not exceeding 1 day). The study lists 3 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 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.