Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients

May 7, 2024 updated by: University of Sao Paulo General Hospital
The effects of different degrees of head-of-bed elevation on respiratory mechanics are poorly explored in the literature, and no study has investigated such effects using electrical impedance tomography, esophageal and gastric balloons to identify the ideal angle for optimizing respiratory mechanics. The hypothesis is that there is a optimal degree for the respiratory mechanics.

Study Overview

Status

Status

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

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

Respiratory mechanics and regional ventilation will be monitored using electrical impedance tomography (Enlight 2100, Timpel Medical®, Brazil) . Esophageal and gastric pressures will be obtained through esophageal and gastric balloon catheters (Nutrivent®) (validation concerning to modified Baydur maneuver - slope delta esophageal pressure/delta airway pressure (0,8-1,2). We are using the hardware Pneumodrive (Biônica, Recife, Brazil) to record and store the esophageal, gastric and airway pressures, these data will be analyzed using LabVIEW 7.1 (Pneumobench).

Initially, patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation.

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 (Estimated)

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.
40

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcelo C Amato, MD, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients under invasive mechanical ventilation, intubated due to respiratory failure

Exclusion Criteria:

  • Hemodynamics instability, contraindication for monitoring with esophageal and gastric catheters, and Electrical impedance tomography, no authorization of medical team of the intensive care unit, and contraindication for lung recruitment maneuver

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Sequential head-of-bed elevation
Patients will be positioned at 0 degrees of head-of-bed elevation, and after stabilization of the plethysmogram, data from electrical impedance tomography, hemodynamics, and arterial blood gas will be collected (arterial blood will be drawn by a nurse or physician). Sequentially and in the same manner, the bed will be adjusted to 10, 20, 30, and 40 degrees (the same data will be collected, except for the arterial blood sample, which will only be collected at the 40-degree elevation). Then, an alveolar recruitment maneuver will be performed, followed by a PEEP titration with 10-degree of head-of-bed elevation, and the data will be collected just as in the 0° and 40° steps.
Other: Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation
Patients will be sequentially positioned at 0, 10, 20, 30, and 40 degrees of head-of-bed elevation. An alveolar recruitment maneuver will be performed. For patients with body mass index ≤ 30 kg/m^2, the maneuver will be conducted in pressure control mode, pressure control = 15 cmH2O, respiratory rate = 20 breaths per minute, and the PEEP will be increased in steps of 5 up to 30 cmH2O. For patients with body mass index > 30, the PEEP will be increased up to 35. Then, a PEEP titration will be performed, tidal volume = 5 mL/Kg, respiratory rate = 25 breaths per minute, and the PEEP will be decreased from 24 down to 4 cmH2O in steps of 2 cmH2O with 30 seconds in each PEEP level. The PEEP titration software of Enlight 2100 will be used to determine the ideal PEEP, defined as the PEEP level with a collapse less than 5%. The alveolar recruitment maneuver will be performed again to reopen the lungs. Then, data will be collected, as with the 0 and 40-degree steps, with ideal PEEP.

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
Respiratory system compliance
Time Frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Respiratory system compliance (mL/cmH2O) will be measured using electrical impedance tomography monitoring (Enlight 2100, Timpel Medical®, Brazil).
At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Lung compliance
Time Frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Lung compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings. By knowing the respiratory system and chest wall compliance, the lung compliance will be calculated. (1/respiratory system compliance = 1/chest wall compliance + 1/lung compliance)
At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Chest wall compliance
Time Frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation

Chest wall compliance (mL/cmH2O) will be measured offline using the esophageal pressure tracings.

Chest wall compliance = tidal volume / delta esophageal pressure
At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation

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
Oxygenation
Time Frame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Oxigenation will be assessed using the partial pressure arterial oxygen/fraction inspired oxygen ratio. Partial pressure arterial oxygen measured in the blood sample at the of each step and the fraction inspired oxygen set during the blood sample collection will be used.
At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Pressure between patient skin surface and the mattress
Time Frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
ForeSite PT (XSENSOR Technology Corporation, Patient Monitoring System) will be used to measure the pressure between patient's skin surface and the mattress. A monitor connected to this sensor provides continuous pressure monitoring, and the data will exported for subsequent offline analysis of the sacral and occipital regions.
At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Hemodynamics satefy of keeping low degrees of head of the elevation
Time Frame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Arterial blood pressure provided by the multiparameter monitor. Data will be noted in each degree.
At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
Gastric pressure
Time Frame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Gastric pressure will be measured offline using the gastric pressure tracings.
At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation

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 General Hospital

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: Marcelo BP Amato, MD, PhD, University of Sao Paulo General Hospital

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.
October 15, 2023

Primary Completion (Estimated)

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.
April 1, 2025

Study Completion (Estimated)

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 1, 2025

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).
April 24, 2024

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.
May 7, 2024

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.
May 10, 2024

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.
May 10, 2024

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.
May 7, 2024

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.
April 1, 2024

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.
  • 68464523.9.0000.0068

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

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.

Clinical Trials on Respiratory Failure

Clinical Trials on Sequencial increasing of head of the bed elevation and alveolar recruitment maneuver followed by a PEEP titration with 10° of head of the elevation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings