Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06508008

Rapid and Safe Sputum Suction Method Validation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Honglei Wu, MS

CONTACT

[email protected]

+8613862749927

MS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

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

Primary outcomes

  1. Blood oxygen saturation before and after sputum aspiration

    Time frame: Not exceeding 1 day

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

  2. Suctioning time

    Time frame: Not exceeding 2 minute

    All time required for sputum suction process

  3. Degree of airway bleeding

    Time frame: Not exceeding 30 minute

    Use a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light.

Secondary outcomes

  1. Patient family satisfaction

    Time frame: Not exceeding 1 day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Honglei Wu, MS

CONTACT

[email protected]

+8613862749927

You Lu, BS

CONTACT

[email protected]

+8613962910607

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.