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Rapid and Safe Sputum Suction Method Validation

Verification of the Effect of Intermittent Negative Pressure Sputum Suction Through Oral Pharyngeal Ventilation Tube in Comatose Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06508008
Enrollment
900
Registered
2024-07-18
Start date
2024-02-18
Completion date
2026-08-18
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sputum

Brief 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.

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.

Interventions

PROCEDUREcontinuous 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.

PROCEDUREIntermittent 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

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Clinical diagnosis of stroke; 2. Clinical diagnosis of comatose;

Exclusion criteria

* 1\. Clinical diagnosis of multiple organ failure; 2. Clinical diagnosis of multiple organ bleeding;

Design outcomes

Primary

MeasureTime frameDescription
Blood oxygen saturation before and after sputum aspirationNot exceeding 1 dayThe degree of binding between oxygen and hemoglobin (Hb) in arterial blood
Suctioning timeNot exceeding 2 minuteAll time required for sputum suction process
Degree of airway bleedingNot exceeding 30 minuteUse a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light.

Secondary

MeasureTime frameDescription
Patient family satisfactionNot exceeding 1 dayAfter 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.

Countries

China

Contacts

CONTACTHonglei Wu, MS
wu_honglei@163.com+8613862749927
CONTACTYou Lu, BS
490944983@qq.com+8613962910607
STUDY_CHAIRTao Zhang, MD

Ethics Committee of Nantong University Affiliated Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026