NCT05281536

Brief Summary

OBJECTIVES: The trunk inclination from semirecumbent to lying supine improves lung mechanics and reduces end-expiratory lung volume in Acute Respiratory Distress Syndrome (ARDS) patients. Besides, it can improve the ventilatory ratio and PaCO2, although the effects and mechanisms are not entirely elucidated. Therefore, this study aimed to evaluate the effects of trunk tilt from 45° to 10° on CO2 removal efficiency. DESIGN: Quasi-experimental study. SETTING: A medical ICU in Chile. PATIENTS: Twenty-two patients with ARDS. INTERVENTION: Patients in pressure-controlled ventilation underwent three 60-minute steps in which trunk inclination was changed from 45° (baseline) to 10° (intervention) and back to 45° (control) in the last step. Respiratory mechanics, arterial blood gas analysis, dead space by volumetric capnography, and electrical impedance tomography were recorded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

March 7, 2022

Last Update Submit

November 14, 2022

Conditions

Keywords

Trunk InclinationPostural changeDead spaceARDS

Outcome Measures

Primary Outcomes (2)

  • Changes in PaCO2

    Determine the effects of postural changes from 45° to 10° on PaCO2

    60 minutes each phase

  • Changes in Bohr's dead-space

    Determine the effects of postural changes from 45° to 10° on Bohr's dead-space

    60 minutes each phase

Study Arms (1)

Postural Changes from 45° to 10° in supine decubitus

EXPERIMENTAL

Postural changes from 45° to 10° in supine decubitus Three times of 60 minutes each step before (45°, baseline) - during (10°, intervention) - after (45°, control)

Other: Ppostural change from 45° to 10° in supine position

Interventions

The intervention will be a postural change from 45° to 10° in a semi-recumbent position of ARDS patients connected to mechanical ventilation.

Postural Changes from 45° to 10° in supine decubitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Admitted to Intensive Care with mild, moderate, or severe ARDS according to the Berlin classification
  • Less than 72 hours of connection to mechanical ventilation.
  • Depth Sedation-analgesia.
  • Acceptance by the legal representative to participate in the study.

You may not qualify if:

  • Pleural tube - bronchopulmonary fistula.
  • Prone position
  • Hypovolemic shock with active bleeding.
  • Intracranial hypertension.
  • Gastric residue greater than 300 ml in the last 6 hours
  • Hemodynamic instability that requires a progressive increase in the dose of vasopressors
  • Temperature variations greater than 0.5 ° C in the last 2 hours
  • Acute heart failure
  • Chronic respiratory disease (FEV1 \<50% predicted).
  • Patients who do not have an arterial line.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clínica Las Condes

Santiago, Santiago Metropolitan, 13114, Chile

Location

Martín Hernán Benites

Santiago, Santiago Metropolitan, 7550000, Chile

Location

Related Publications (4)

  • Marrazzo F, Spina S, Forlini C, Guarnieri M, Giudici R, Bassi G, Bastia L, Bottiroli M, Fumagalli R, Langer T. Effects of Trunk Inclination on Respiratory Mechanics in Patients with COVID-19-associated Acute Respiratory Distress Syndrome: Let's Always Report the Angle! Am J Respir Crit Care Med. 2022 Mar 1;205(5):582-584. doi: 10.1164/rccm.202110-2360LE. No abstract available.

    PMID: 34982652BACKGROUND
  • Tusman G, Gogniat E, Bohm SH, Scandurra A, Suarez-Sipmann F, Torroba A, Casella F, Giannasi S, Roman ES. Reference values for volumetric capnography-derived non-invasive parameters in healthy individuals. J Clin Monit Comput. 2013 Jun;27(3):281-8. doi: 10.1007/s10877-013-9433-x. Epub 2013 Feb 7.

  • Mentzelopoulos SD, Roussos C, Zakynthinos SG. Static pressure volume curves and body posture in acute respiratory failure. Intensive Care Med. 2005 Dec;31(12):1683-92. doi: 10.1007/s00134-005-2838-3. Epub 2005 Oct 26.

  • Rehder K. Postural changes in respiratory function. Acta Anaesthesiol Scand Suppl. 1998;113:13-6. doi: 10.1111/j.1399-6576.1998.tb04980.x.

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Martín Benites, MD

    Clínica Las Condes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Data obtained for mechanical ventilation, volumetric capnography, and electric impedance tomography will be download by different investigators when all patients have been recruited. The results will be analyzed by statisticians, who will not know the participant's identification
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The intervention will be a postural change from 45° to 10° in a semi-recumbent position of ARDS patients connected to mechanical ventilation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

April 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

I would have to request authorization from the institutional ethics committee to provide the information. Should you need any further information, please do not hesitate to contact me. benitesmartinh@gmail.com

Locations