Airway Occlusion Measured During Non-invasive Ventilation to Assess Respiratory Effort

Healthy Volunteers Clinical Trial

Official title:

Airway Occlusion Measured During Non-invasive Ventilation to Assess Respiratory Effort

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576246
• Other study ID #: Airway occlusion V1
• Status: Not yet recruiting
• Start date: October 30, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: October 2022
• Source: Clinica Olivos SMG
• Contact: Marina Busico, chief RT
• Phone: 5491141627491
• Email: marina.busico[@]clinicaolivos.com.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). It eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) complications; however, on the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may predispose the patient to the onset of self-inflicted lung injury (SILI). Therefore, measuring the level of inspiratory effort is recommended.The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Description:

Non-invasive ventilation (NIV) is extensively used in critical care settings and emergency departments for a variety of aetiologies but specially for acute respiratory failure (ARF). Recommendations based on the GRADE methodology were addressed on several conditions such as exacerbation of chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema, de novo hypoxaemic respiratory failure, immunocompromised patients, chest trauma, palliative care, post-operative care, weaning and post-extubation period. NIV eliminates morbidity related to the endotracheal tube and use of sedatives so it reduces intensive care unit (ICU) acquired pneumonia, diaphragmatic atrophy, ICU acquired weakness and delirium. On the other hand, the harmful effects of spontaneous breathing through the intensity of inspiratory effort may follow a critical increase in respiratory drive, thus producing uncontrolled tidal change in dynamic transpulmonary pressure (PLdyn) that would increase the risk of injury to the dependent lung and predispose the patient to the onset of self-inflicted lung injury (SILI). High positive end-expiratory pressure (PEEP) renders spontaneous effort non injurious. P-SILI may worsen the clinical outcome of patients who require endotracheal intubation after having received noninvasive respiratory support. The underlying mechanisms of SILI are heterogeneous and include the pendelluft phenomenon, increased transvascular pressure gradient aggravating alveolar damage, excessive diaphragmatic loading with impaired systemic oxygen delivery and muscle injury. Therefore, measuring the level of inspiratory effort is recommended. Esophageal manometry is a precise estimate of the changes in pleural pressure and is considered the gold standard to measure respiratory effort. Tonelli et al. measured tidal change in esophageal pressure (ΔPes) in patients with acute hypoxic de novo respiratory failure on NIV and demonstrated a median baseline value of ΔPes of 34 cmH2O that was significantly reduced within the first 2 hours of ventilation in patients who were successful in the NIV trial, whereas those failing the NIV trial did not show a significant reduction. However, esophageal manometry is rarely available bedside in acute settings on severe patients with respiratory distress so other ways of measuring inspiratory effort have been assessed, such as nasal pressure swings or the patient's respiratory effort against the occluded airway (ΔPocc). The latest was demonstrated on invasive mechanical ventilation patients. Lopez Navas et al. tried to correlate the inspiratory pressure-time product (PTPinsp) from transdiaphragmatic pressure to a novel expiratory occlusion method of 0.2 s in healthy volunteers with NIV on different settings; however, their results through Bland-Altman analysis of PTPinsp revealed mean differences between -4.22 and 7.57 cmH2O (SD 0.77- 8.52) and considerable differences between subjects. Moreover, Dargent A, et al. explored the feasibility of a noninvasive respiratory drive evaluation using ventilator-derived data as P0.1, clinical information and diaphragm ultrasound in COVID 19 patients on CPAP session with 5 cmH2O. They showed that P0.1 was achievable during NIV with a median value of 4.4 [2.7-5.1] cmH2O and not correlated with leaks, though they were small (5 [4-7] l/min); nevertheless, P0.1 was not accurate at predicting the risk of intubation but it was limited by its small sample size. In addition, P0.1 has been previously evaluated (with other physiological parameters) on NIV in COPD patients to predict post-extubation respiratory distress. They reported that only P0.1 recorded 1 h after the discontinuation of mechanical ventilation followed by 30 minutes of 4 cmH2O pressure support ventilation, was significantly different between the patients with and without respiratory distress (4.2 vs 1.8, p < 0.01). Nonetheless, there are no studies that measured bedside the pressure generated by the respiratory muscles during NIV. The aim of this proof-of-concept physiological study was to describe the correlation between ΔPocc measured on the ventilator and ΔPes in healthy subjects with NIV.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy subjects over 18 years old who wish to participate were included.

Exclusion Criteria:

• Exclusion criteria was the presence of any esophageal disease or COPD.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Diagnostic Test:
• airway pressure occlusion measurement
Flow, airway pressure (Paw), and esophageal pressure (Pes) will be recorded for 10 minutes on different NIV settings: during each one, three end-expiratory airway occlusions will be applied at random intervals. Each occlusion was maintained for the duration of a single breath deflection in Paw from PEEP, confirmed by the return of Paw to baseline.

Locations

Country	Name	City	State
Argentina	Swiss Medical Group	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Olivos SMG

Country where clinical trial is conducted

Argentina, 

References & Publications (15)

Battaglini D, Robba C, Ball L, Silva PL, Cruz FF, Pelosi P, Rocco PRM. Noninvasive respiratory support and patient self-inflicted lung injury in COVID-19: a narrative review. Br J Anaesth. 2021 Sep;127(3):353-364. doi: 10.1016/j.bja.2021.05.024. Epub 2021 — View Citation

Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. — View Citation

Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary dri — View Citation

Dargent A, Hombreux A, Roccia H, Argaud L, Cour M, Guérin C. Feasibility of non-invasive respiratory drive and breathing pattern evaluation using CPAP in COVID-19 patients. J Crit Care. 2022 Jun;69:154020. doi: 10.1016/j.jcrc.2022.154020. Epub 2022 Mar 17 — View Citation

Gainnier M, Roch A, Forel JM, Thirion X, Arnal JM, Donati S, Papazian L. Effect of neuromuscular blocking agents on gas exchange in patients presenting with acute respiratory distress syndrome. Crit Care Med. 2004 Jan;32(1):113-9. — View Citation

Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.134 — View Citation

Hilbert G, Gruson D, Portel L, Vargas F, Gbikpi-Benissan G, Cardinaud JP. Airway occlusion pressure at 0.1 s (P0.1) after extubation: an early indicator of postextubation hypercapnic respiratory insufficiency. Intensive Care Med. 1998 Dec;24(12):1277-82. — View Citation

Lopez-Navas K, Brandt S, Strutz M, Gehring H, Wenkebach U. Non-invasive determination of respiratory effort in spontaneous breathing and support ventilation: a validation study with healthy volunteers. Biomed Tech (Berl). 2014 Aug;59(4):335-41. doi: 10.15 — View Citation

Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Sponta — View Citation

Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS c — View Citation

Telias I, Spadaro S. Techniques to monitor respiratory drive and inspiratory effort. Curr Opin Crit Care. 2020 Feb;26(1):3-10. doi: 10.1097/MCC.0000000000000680. Review. — View Citation

Tonelli R, Cortegiani A, Marchioni A, Fantini R, Tabbì L, Castaniere I, Biagioni E, Busani S, Nani C, Cerbone C, Vermi M, Gozzi F, Bruzzi G, Manicardi L, Pellegrino MR, Beghè B, Girardis M, Pelosi P, Gregoretti C, Ball L, Clini E. Nasal pressure swings as — View Citation

Tonelli R, Fantini R, Tabbì L, Castaniere I, Pisani L, Pellegrino MR, Della Casa G, D'Amico R, Girardis M, Nava S, Clini EM, Marchioni A. Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in De Novo Respi — View Citation

Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. Spontaneous breathing during lung-protective ventilation in an experimental acute lung injury model: high transpulmonary pressure associated with strong spontaneous breathing effort may worsen lung i — View Citation

Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between Poccvent and Pesflux	The primary outcome was the correlation between the ?Poccvent and ?Pesflux on each ventilator setting as independent measures and the agreement between two sets of measurements on each ventilator setting.	The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.
Secondary	Correlation between Pccvent and PTPmus	The secondary outcome was the correlation between ?Poccvent the mean PTPmus during the last minute of ventilation for each ventilator setting.	The subjects will be measured on each ventilator setting (3 settings) for 10 minutes.