Efficacy of Two Intermittent Subglottic Secretion

March 11, 2019 updated by: The First Hospital of Jilin University

Efficacy of Intermittent Subglottic Secretion Lavage Combined With Aspiration Preventing Ventilator Associated Pneumonia in Patients With Severe Neurological Disease：A Single-center Randomized Controlled Trial

The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)

Exclusion Criteria:

  • Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lavage combined with aspiration
Intermittent subglottic secretions lavage combined with aspiration
Procedure: Subglottic secretion lavage combined with aspiration
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.
ACTIVE_COMPARATOR: Pure aspiration
Intermittent subglottic secretions aspiration
Procedure: Subglottic secretion aspiration
Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of ventilator-associated pneumonia
Time Frame: through study completion, an average of 10 months
is pneumonia that occurs when an artificial airway is established and mechanically ventilated
through study completion, an average of 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of draining duct blockage
Time Frame: through study completion, an average of 10 months
If mucus flow stopped during subglottic suctioning with a sudden increase of the negative pressure in the proximal port of the suction suggesting a probable occlusion
through study completion, an average of 10 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
length of mechanical ventilation
Time Frame: through study completion, an average of 10 months
length of mechanical ventilation
through study completion, an average of 10 months
The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
Time Frame: through study completion, an average of 10 months
The coincidence rate between pathogens of subglottic secretions and the lower respiratory tract
through study completion, an average of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSD-SSLACA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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