Rapid and Safe Sputum Suction Method Validation

NCT06508008 | Recruiting DMC

• 1 other identifier: 2024-K119-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Sputum

Outcome Measures

Primary Outcomes (3)

• Blood oxygen saturation before and after sputum aspiration

  The degree of binding between oxygen and hemoglobin (Hb) in arterial blood

  Not exceeding 1 day

• Suctioning time

  All time required for sputum suction process

  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.

  Not exceeding 30 minute

Secondary Outcomes (1)

• Patient family satisfaction

  Not exceeding 1 day

Study Arms (2)

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

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.

Interventions

continuous negative pressure suction 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

Intermittent negative pressure sputum suction through oral pharyngeal airway 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

Intermittent negative pressure sputum suction through oral pharyngeal airway

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical diagnosis of stroke; 2. Clinical diagnosis of comatose;

You may not qualify if:

• \. Clinical diagnosis of multiple organ failure; 2. Clinical diagnosis of multiple organ bleeding;

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Study Officials

• Tao Zhang, MD

  Ethics Committee of Nantong University Affiliated Hospital

  STUDY CHAIR

Central Study Contacts

Honglei Wu, MS

CONTACT

+8613862749927; wu_honglei@163.com

You Lu, BS

CONTACT

+8613962910607; 490944983@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 18, 2024
• Study Start: February 18, 2024
• Primary Completion: July 9, 2024
• Study Completion: August 18, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)