Oxygen Consumption (VO2), Effort, and Weaning in the Mechanically Ventilated Patient in the Intensive Care Unit (ICU)

NCT06391424 | Recruiting

• 1 other identifier: P23.068
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

In patients who are mechanically ventilated for more than 72 hours weaning failure is a common issue. The Spontaneous breathing trial (SBT) is often done to assess if the patient can be extubated with a high chance of success. However, re-intubation rates are between 15 - 20 % after a successful SBT. The rapid shallow breathing index (RSBI) is an important parameter used in an SBT. Because the high incidence of extubation failure (re-intubation within 48 hours) a search for a better parameter than the RSBI is warranted. Using the measured end-tidal oxygen (etO2) of mechanically ventilated patients it is possible to calculate the VO2, which is a measure of patient effort. The VO2 is a parameter with the potential to predict weaning success or failure, together with other parameters of patient effort like the work of breathing (WOB), pressure time product (PTP) and esophageal pressure swings, reflecting muscle strength of the diaphragm. Therefore, the investigators want to investigate if these parameters are associated with an SBT success or failure.

Conditions

Critical Illness; Intensive Care Unit; Oxygen Consumption; Weaning Failure; Mechanical Ventilation; Spontaneous Breathing Trial

Outcome Measures

Primary Outcomes (2)

• Incidence of weaning failure

  weaning failure is defined as not meeting the criteria for a succesful spontaneous breathing trial (SBT) or extubation failure, defined as the need for re-intubation within 48 hours, after a succesful SBT and subsequent extubation.

  48 hours after SBT

• Differences of oxygen consumption during SBT

  The values of oxygen consumption (in milliliter/minute) and the differences between start, during, and end of the SBT.

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

Secondary Outcomes (4)

• Differences of esophageal pressure swings measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of work of breathing measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of pressure time product measured with an esophageal catheter during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

• Differences of rapid shallow breathing index during SBT

  10 minutes before, through SBT (average of 30 minutes) and 10 minutes after SBT

Study Arms (1)

Spontaneous Breathing Trial

Patients who will undergo a spontaneous breathing trial

Diagnostic Test: Spontaneous Breathing Trial

Interventions

Spontaneous Breathing Trial DIAGNOSTIC_TEST

Patients will undergo an SBT to determine whether they are ready for extubation.

Spontaneous Breathing Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended population consists of adults who are mechanically ventilated in the ICU and meet the criteria for a regular spontaneous breathing trial according to the ruling LUMC protocol.

You may qualify if:

• Age above 18 years
• \> 24 hours mechanically ventilated
• Eligible for a spontaneous breathing trial according to the clinical team
• Regular SBT ("Regulier SBT") according to the Leiden University Medical Center (LUMC) protocol
• Hemodynamically stable
• Esophageal Catheter in situ

You may not qualify if:

• Severe chronic obstructive pulmonary disease (COPD) (Gold class IV) if it results in a non regular SBT according to the LUMC protocol.
• Heart failure (LVEF \<30%) if it results in a non regular SBT according to the LUMC protocol
• Known pregnancy

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

NOT YET RECRUITING

Related Publications (11)

• Trudzinski FC, Neetz B, Bornitz F, Muller M, Weis A, Kronsteiner D, Herth FJF, Sturm N, Gassmann V, Frerk T, Neurohr C, Ghiani A, Joves B, Schneider A, Szecsenyi J, von Schumann S, Meis J. Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review. Respiration. 2022;101(10):959-969. doi: 10.1159/000525604. Epub 2022 Aug 17.

  PMID: 35977525 BACKGROUND

• Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.

  PMID: 27626706 BACKGROUND

• Epstein SK, Ciubotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest. 1997 Jul;112(1):186-92. doi: 10.1378/chest.112.1.186.

  PMID: 9228375 BACKGROUND

• Li F, Nie J, Lu Y, Tong TK, Yi L, Yan H, Fu FH, Ma S. The impact of intermittent exercise in a hypoxic environment on redox status and cardiac troponin release in the serum of well-trained marathon runners. Eur J Appl Physiol. 2016 Oct;116(10):2045-51. doi: 10.1007/s00421-016-3460-5. Epub 2016 Aug 29.

  PMID: 27572505 BACKGROUND

• Pham T, Telias I, Beitler JR. Esophageal Manometry. Respir Care. 2020 Jun;65(6):772-792. doi: 10.4187/respcare.07425.

  PMID: 32457170 BACKGROUND

• Jubran A, Grant BJ, Laghi F, Parthasarathy S, Tobin MJ. Weaning prediction: esophageal pressure monitoring complements readiness testing. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1252-9. doi: 10.1164/rccm.200503-356OC. Epub 2005 Mar 11.

  PMID: 15764727 BACKGROUND

• McClave SA, Kleber MJ, Lowen CC. Indirect calorimetry: can this technology impact patient outcome? Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):61-7. doi: 10.1097/00075197-199901000-00011.

  PMID: 10453332 BACKGROUND

• Takala J, Keinanen O, Vaisanen P, Kari A. Measurement of gas exchange in intensive care: laboratory and clinical validation of a new device. Crit Care Med. 1989 Oct;17(10):1041-7. doi: 10.1097/00003246-198910000-00015.

  PMID: 2676345 BACKGROUND

• Bellani G, Foti G, Spagnolli E, Milan M, Zanella A, Greco M, Patroniti N, Pesenti A. Increase of oxygen consumption during a progressive decrease of ventilatory support is lower in patients failing the trial in comparison with those who succeed. Anesthesiology. 2010 Aug;113(2):378-85. doi: 10.1097/ALN.0b013e3181e81050.

  PMID: 20613464 BACKGROUND

• Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. P0.1 is an Unreliable Measure of Effort in Support Mechanical Ventilation in Comparison With Esophageal-Derived Measures of Effort: A Comparison Study. Crit Care Med. 2025 Aug 1;53(8):e1650-e1658. doi: 10.1097/CCM.0000000000006745. Epub 2025 Jun 11.

  PMID: 40638487 DERIVED

• Smits FE, Rietveld PJ, Snoep JWM, van der Velde-Quist F, de Jonge E, Schoe A. Oxygen consumption, effort, and weaning in the mechanically ventilated patient in the intensive care unit: The extubate study: A protocol for an observational study. Respir Med. 2025 Feb;237:107949. doi: 10.1016/j.rmed.2025.107949. Epub 2025 Jan 16.

  PMID: 39826764 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abraham Schoe, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence E Smits, MSc

CONTACT

+31 (0)71-5262164; f.e.smits@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist, Department of Intensive Care, Principal Investigator, Associate professor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: April 30, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (2)