Rapid and Safe Sputum Suction Method Validation

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Sputum

Treatments: Procedure: Intermittent negative pressure sputum suction through oral pharyngeal airway; Procedure: continuous negative pressure suction

Study type: Interventional

Funder types: Other

Identifiers

NCT06508008

2024-K119-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Intermittent negative pressure sputum suction through oral pharyngeal airway

Experimental group

Description:

(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

Treatment:

Procedure: continuous negative pressure suction

Procedure: Intermittent negative pressure sputum suction through oral pharyngeal airway

continuous negative pressure suction

No Intervention group

Description:

(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.