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

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.

Study Overview

• Status: Recruiting
• Conditions: Sputum
• Intervention / Treatment: Procedure: continuous negative pressure suction; Procedure: Intermittent negative pressure sputum suction through oral pharyngeal airway

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.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Honglei Wu, MS; Phone Number: +8613862749927; Email: wu_honglei@163.com
• Study Contact Backup: Name: You Lu, BS; Phone Number: +8613962910607; Email: 490944983@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: MS
      • Contact: Honglei Wu, MS; Phone Number: +8613862749927; Email: wu_honglei@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient family satisfaction	After 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.	Not exceeding 1 day

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Chair: Tao Zhang, MD, Ethics Committee of Nantong University Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Actual): July 9, 2024
• Study Completion (Estimated): August 18, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024-K119-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No