Rapid and Safe Sputum Suction Method Validation

NCT ID: NCT06508008

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-18
• Study Completion Date: 2024-08-18

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.

Conditions

Sputum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

continuous negative pressure suction

Intervention Type: PROCEDURE

(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 airway

Intervention Type: PROCEDURE

(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

(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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Zhang, MD

Role: STUDY_CHAIR

Ethics Committee of Nantong University Affiliated Hospital

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Honglei Wu, MS

Role: CONTACT

wu_honglei@163.com

+8613862749927

You Lu, BS

Role: CONTACT

490944983@qq.com

+8613962910607

Facility Contacts

Honglei Wu, MS

Role: primary

wu_honglei@163.com

+8613862749927

MS

Role: backup

Other Identifiers

2024-K119-01

Identifier Type: -

Identifier Source: org_study_id