Effects of Trunk Postural Change on CO2 Removal Efficiency in ARDS Patients: Quasi-experimental Study
1 other identifier
interventional
22
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedNovember 17, 2022
November 1, 2022
1.5 years
March 7, 2022
November 14, 2022
Conditions
Keywords
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
EXPERIMENTALPostural changes from 45° to 10° in supine decubitus Three times of 60 minutes each step before (45°, baseline) - during (10°, intervention) - after (45°, control)
Interventions
The intervention will be a postural change from 45° to 10° in a semi-recumbent position of ARDS patients connected to mechanical ventilation.
Eligibility Criteria
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
Martín Hernán Benites
Santiago, Santiago Metropolitan, 7550000, Chile
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: 34982652BACKGROUNDTusman 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.
PMID: 23389294RESULTMentzelopoulos 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.
PMID: 16249926RESULTRehder K. Postural changes in respiratory function. Acta Anaesthesiol Scand Suppl. 1998;113:13-6. doi: 10.1111/j.1399-6576.1998.tb04980.x.
PMID: 9932113RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martín Benites, MD
Clínica Las Condes
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
- 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