Acute Effects of Open and Closed Suction Systems in Mechanically Ventilated Patients

August 16, 2017 updated by: Talita Dias da Silva, University of Sao Paulo

Acute Effects of Open and Closed Suction Systems on Pulmonary Mechanics and Cardiovascular Function in Mechanically Ventilated Patients

Seventy-one patients in intensive care were randomized for initial treatment with open suction systems or closed suction systems in a cross-over design. Pulmonary and cardiovascular physiology was assessed immediately before and after three 10-second aspirations per suction. Were analyzed the effect of each suction system on physiologic parameters while adjusting for their respective values prior to suction.

Study Overview

Status

Status

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

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

Study Participants. The sample consisted of 71 subjects, both genders, hospitalized in intensive care units. This study protocol was approved by the Research Ethics Committee of Heliopolis Hospital - Sao Paulo - Brazil.

Patients were randomized in the following way: patients hospitalized in the odd beds of ICU were aspirated initially by open suction system (OSS) and later by the closed suction system (CSS); patients hospitalized in the even beds were aspirated by CSS, initially, and subsequently by the OSS.

Cardiopulmonary measures: Eligible patients were evaluated for the presence or absence of neural stimulation to spontaneous ventilation (drive breathing). If the patients showed spontaneous respiratory movements, they were sedated to the level four of Ramsay scale. After this initial evaluation, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), respiratory rate (RR), oxygen saturation (SAT), tidal volume (Vt), peak pressure (Ppeak), plateau pressure (Pplat), positive end expiratory pressure (PEEP), and inspiratory flow (V) were measured. The HR and SAT data were collected by visualization of DX 2010 multiparameter monitor from Dixtal. SBP, DBP and MBP were obtained by a single measurement provided by the same monitor. Data of peak pressure, plateau pressure, positive end expiratory pressure, inspiratory flow and tidal volume were used to calculate compliance (C) and airway resistance (R). Data were collected before and after tracheal aspiration.

Pulmonary Suction: After the initial data were obtained, patients who were under volume-controlled ventilation mode (VCV) were submitted to the first aspiration procedure according to randomization described above. Patients who were under pressure-controlled ventilation mode (PCV) were changed to VCV mode, respecting the individual mean tidal volume, which means that the tidal volume of the patient under PCV would be used to ventilate in VCV. All patients were ventilated with a Savina (Drager) mechanical ventilator. Aspiration procedures and data collection were done by a health care professional unaware of the study regimes or objectives. After the measurement of the initial parameters, patients underwent the procedure of aspiration in an open or closed system according to the randomization described above. All patients were aspirated by a system that had not been used previously. The procedure was timed and required 10 seconds to insert and remove the aspiration catheter, with each aspiration performed three times. The outside diameter of the aspiration catheter had half the inner diameter of the endotracheal tube, and the negative pressure was adjusted between 70 and 100 mmHg. At the end of the aspiration procedure, physiological assessments were repeated. Patients were returned to nursing care and underwent the second procedure after six hours from initial aspiration.

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 (Actual)

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.
71

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients over 18 years old;
  • intubated with a 7.5mm endotracheal tube;
  • mechanically ventilated.

Exclusion Criteria:

  • upper gastrointestinal bleeding;
  • hemodynamic instability;
  • airway bleeding;
  • previous lung diseases.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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: Closed suction system
Patients in mechanical ventilation were aspirated with closed suction system.
Procedure: Closed suction system
In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.
Active Comparator: Open suction system
Patients in mechanical ventilation were aspirated with open suction system.
Procedure: Open suction system
In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.

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
Improvements in Pulmonary parameters when comparing closed and open suction systems.
Time Frame: 1 day
Assessment of Peak Pressure (cmH20) in both closed and open suction systems.
1 day
Improvements in Cardiovascular parameters when comparing Closed and open suction systems.
Time Frame: 1 day
Assessment of Blood Pressure (mmHg) in both closed and open suction systems.
1 day

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.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo D Raimundo, Ph.D., Faculdade de Medicina do ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
February 2, 2015

Primary Completion (Actual)

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.
July 15, 2016

Study Completion (Actual)

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.
April 17, 2017

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).
July 18, 2017

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.
August 16, 2017

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.
August 21, 2017

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.
August 21, 2017

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.
August 16, 2017

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.
August 1, 2017

More Information

Terms related to this study

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.
  • 467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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