Protocolized Ventilator Weaning Verses Usual Care

October 28, 2018 updated by: Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University

Protocolized Ventilator Weaning Verses Usual Care: A Randomized Controlled Trial

Protocol-driven ventilator weaning strategies utilizing spontaneous breathing trials (SBT) reportedly result in shorter intubation duration and intensive care unit (ICU) length-of-stay (LOS). Investigators compared respiratory therapy (RT)-driven protocolized ventilator weaning (PW) verses usual care (UC) as it pertains to physiologic respiratory parameters, intubation duration, extubation success/reintubation rates, and ICU LOS. The study was a prospective multicenter randomized controlled trial in 6 ICUs at 6 academic-affiliated hospitals in a resource limited setting. Extubation readiness was determined by the attending physician (UC) or the respiratory therapist (PW) using pre-defined criteria and SBT. Physiologic variables, serial blood gas measurements, and weaning indices were assessed including rapid shallow breathing index (RSBI), negative inspiratory force (NIF), occlusion pressure (P0.1), dynamic and static compliance (Cdyn and Cs).

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

This was a prospective multicenter randomized controlled trial in 6 closed ICUs with 24/7 in-house intensivist coverage at 6 academic-affiliated medical centers in a resource limited setting from October 18, 2007 to May 03, 2014. All parts of the study were reviewed according to the Consolidated Standards for Reporting Trials (CONSORT) statement. Crossover was not allowed. Participants were blinded to randomization group, as were the healthcare providers and statistician. Randomization was accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc.). Block randomization was performed by a computer generated random number list prepared by a statistician. Allocation consignment occurred through confidential communication between the patient's nurse and a third party not involved in recruitment. The data analyzer was blinded to group randomization and was not present during ventilator weaning. There were no important changes to methods after trial commencement. The study ended because it achieved the necessary sample size.

Pparticipants were randomly assigned to ventilator weaning either by protocolized methodology or by usual care (UC). All patients were ventilated using Dräger Evita® XL or Evita® 4 ventilators (Dräeger Medical, Inc., Lubeck, Germany). In the PW group, weaning and extubation readiness was determined by the RT using pre-defined criteria and the result of a SBT. Pre-defined weaning criteria included: (1) patent upper airway; (2) ability to protect airway (defined by mental status and presence of adequate gag and cough reflexes); (3) ability to clear secretions; (4) decreasing secretion burden requiring suction not more frequently than every 2 hours; (5) level of support (FiO2 < 50%, PEEP = 5); and (6) hemodynamic stability not requiring chemical (vasopressors, inotropes) or mechanical (e.g. intra-aortic balloon pump, extracorporeal life support) circulatory support. Until the SBT, management of each group was the same. For patients in the UC group, SBT type and determination to extubate was determined by attending physician preference. For participants in the PW group, the SBT type was protocol determined, and extubation decisions were driven by RT. The SBT consisted of continuous positive airway pressure (CPAP) of 5 mmHg with an FiO2 ≤ 0.4. After 3-minutes patients were assessed for appropriateness to continue the SBT by arterial oxygen saturation (SaO2) ≥ 92% without arrhythmias, and a rapid shallow breathing index (RSBI = RR/VT) < 105 breaths/min/L. Specified signs of respiratory distress included respiratory rate (RR)> 30 breaths/minute, SaO2< 90%, heart rate (HR)> 140 breaths/minute, or a sustained increase or decrease of HR of >20%, systolic blood pressure >200 mmHg or <80 mmHg, or agitation, anxiety, or diaphoresis without other identified cause. The SBT was performed for 120 min in accordance with prior studies. At the end of the SBT, the RSBI was re-measured and an arterial blood gas (ABG) was obtained.

In the UC group, the SBT type and extubation decision was determined by the attending intensivist on service based upon neurologic status, airway competence (gag, cough, suction requirements), and negative inspiratory force (NIF) or RSBI measurements. Extubation success was defined as remaining extubated for 48 hours without need for re-intubation or other forms of non-invasive MV.

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.
4200

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted to the ICU
  • Endotracheally intubated on mechanical ventilation ≥ 24 hours
  • Full-code status
  • Informed consent provided by the patient, legal guardian, or healthcare surrogate (prior to ventilator weaning).

Exclusion Criteria:

  • Declining consent
  • Death without ventilator weaning
  • Cardiopulmonary arrest on the ventilator
  • Permanent ventilator dependence
  • Tracheostomy placement for long-term weaning
  • Self-extubation
  • Pulmonary edema
  • Aspiration during the wean
  • Copious secretions and mucus plugging precluding wean
  • Severe obstructive lung disease
  • COPD with hypercapneic respiratory failure
  • Status-post-respiratory arrest
  • Concurrent neurologic / neuromuscular comorbidity
  • Drug or alcohol intoxication
  • Incomplete data.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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: Protocolized Wean
Respiratory therapist determined extubation readiness based on: patent and protected airway; adequate secretion clearance; suction requirement ≤ every 2 hours; FiO2 < 50% and PEEP = 5; and hemodynamic stability without circulatory support. The SBT included CPAP = 5 mmHg at FiO2 ≤ 0.4. Patients were assessed after 3-minutes for appropriateness to continue (SaO2 ≥ 92%; no arrhythmia; RSBI < 105 breaths/min/L). Respiratory distress signs included RR > 30 breaths/min, SaO2< 90%, HR > 140 beats/min, or a sustained change in HR of >20%, systolic BP >200 mmHg or <80 mmHg, or agitation, anxiety, or diaphoresis without other cause. The SBT lasted 120 min in accordance with prior studies. Upon SBT completion, the RSBI was re-measured and an ABG was obtained.
Other: Protocolized wean
Respiratory therapist determined extubation readiness based on: patent and protected airway; adequate secretion clearance; suction requirement ≤ every 2 hours; FiO2 < 50% and PEEP = 5; and hemodynamic stability without circulatory support. The SBT included CPAP = 5 mmHg at FiO2 ≤ 0.4. Patients were assessed after 3-minutes for appropriateness to continue (SaO2 ≥ 92%; no arrhythmia; RSBI < 105 breaths/min/L). Respiratory distress signs included RR > 30 breaths/min, SaO2< 90%, HR > 140 beats/min, or a sustained change in HR of >20%, systolic BP >200 mmHg or <80 mmHg, or agitation, anxiety, or diaphoresis without other cause. The SBT lasted 120 min in accordance with prior studies. Upon SBT completion, the RSBI was re-measured and an ABG was obtained.
No Intervention: Usual Care
In the UC group, the SBT type and extubation decision was determined by the attending intensivist on service based upon neurologic status, airway competence (gag, cough, suction requirements), and negative inspiratory force (NIF) or RSBI measurements.

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
Duration of Intubation
Time Frame: through study completion, an average of 30 days
Duration of mechanical ventilation
through study completion, an average of 30 days

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
Hospital length-of-stay
Time Frame: through study completion, an average of 30 days
Hospital length-of-stay
through study completion, an average of 30 days

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.
Baqiyatallah Medical Sciences 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 (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.
October 18, 2007

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.
May 3, 2014

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.
August 20, 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).
October 4, 2018

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.
October 28, 2018

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.
October 30, 2018

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.
October 30, 2018

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.
October 28, 2018

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.
October 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.
  • BUMS-PWvUC-RCT

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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