Menu
Recruiting NCT06508008

Rapid and Safe Sputum Suction Method Validation

No phase Interventional Sputum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: continuous negative pressure suction, Intermittent negative pressure sputum suction through oral pharyngeal airway.
Who it may be relevant to
Registry conditions: Sputum. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure 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 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

Primary outcome measures

  • Blood oxygen saturation before and after sputum aspiration [Time frame: Not exceeding 1 day]
  • Suctioning time [Time frame: Not exceeding 2 minute]
  • Degree of airway bleeding [Time frame: Not exceeding 30 minute]
Secondary outcome measures (1)
  • Patient family satisfaction [Time frame: Not exceeding 1 day]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 1 center
  • Affiliated Hospital of Nantong University — Nantong

Identifiers

NCT: NCT06508008 · 2024-K119-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗