Skip to main content
Clinical Trials/NCT06409897
NCT06409897RecruitingNot Applicable

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

University of Sao Paulo General Hospital2 sites in 1 country40 target enrollmentStarted: October 15, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
2
Primary Endpoint
Respiratory system compliance

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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).

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)

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

Secondary Outcomes

  • Hemodynamics satefy of keeping low degrees of head of the elevation(At 0, 10, 20, 30, 40-degrees of head-of-bed elevation)
  • Gastric pressure(At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation)
  • Oxygenation(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(At 0, 10, 20, 30, 40-degrees of head-of-bed elevation)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials