Clinical trial NCT06409897: Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
Official title: Respiratory Mechanics Assessment at Different Head of the Bed Elevations in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Pulmonary Disease
Keywords: Respiratory Failure
Pulmonary disease
Intensive care
Respiratory Mechanics
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the participants will be exposed to the same situations (head-of-bed elevations), in the same order. An alveolar recruitment maneuver followed by a PEEP titration with 10-degree head-of-bed elevation will be performed.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory system compliance
timeFrame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
measure: Lung compliance
timeFrame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
measure: Chest wall compliance
timeFrame: 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 outcomes:
measure: Oxygenation
timeFrame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
measure: Pressure between patient skin surface and the mattress
timeFrame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
measure: Hemodynamics satefy of keeping low degrees of head of the elevation
timeFrame: At 0, 10, 20, 30, 40-degrees of head-of-bed elevation
measure: Gastric pressure
timeFrame: At 0 and 40-degrees of head-of-bed elevation, and with titrated PEEP at 10-degrees of head-of-bed elevation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Marcelo BP Amato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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