Adherence to low tidal volume in the transition to spontaneous ventilation in patients with acute respiratory failure in intensive care units in Latin America (SPIRAL): a study protocol

Diniz-Silva, Fabia; Pinheiro, Bruno Valle; Reyes, Luis Felipe; Cavalcanti, Alexandre Biasi; Figueredo, Belinda; Rios, Fernando; Machado, Flávia Ribeiro; Preda, Gabriel; Bugedo, Guillermo; Maia, Israel Silva; Silveira, Leda Tomiko Yamada da; Herrera, Luis; Jibaja, Manuel; Ibarra-Estrada, Miguel; Cestari, Mino; Nin, Nicolás; Roldan, Rollin; Santos, Tiago Mendonça dos; Veiga, Viviane Cordeiro; Bruhn, Alejandro; Ferreira, Juliana Carvalho; ,

doi:10.62675/2965-2774.20240044-en

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Clinical Report • Crit. Care Sci. 36 • 2024 • https://doi.org/10.62675/2965-2774.20240044-en copy

Adherence to low tidal volume in the transition to spontaneous ventilation in patients with acute respiratory failure in intensive care units in Latin America (SPIRAL): a study protocol

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

Patients with acute respiratory failure often require mechanical ventilation to reduce the work of breathing and improve gas exchange; however, this may exacerbate lung injury. Protective ventilation strategies, characterized by low tidal volumes (≤ 8mL/kg of predicted body weight) and limited plateau pressure below 30cmH₂O, have shown improved outcomes in patients with acute respiratory distress syndrome. However, in the transition to spontaneous ventilation, it can be challenging to maintain tidal volume within protective levels, and it is unclear whether low tidal volumes during spontaneous ventilation impact patient outcomes. We developed a study protocol to estimate the prevalence of low tidal volume ventilation in the first 24 hours of spontaneous ventilation in patients with hypoxemic acute respiratory failure and its association with ventilator-free days and survival.

Methods:

We designed a multicenter, multinational, cohort study with a 28-day follow-up that will include patients with acute respiratory failure, defined as a partial oxygen pressure/fraction of inspired oxygen ratio < 300mmHg, in transition to spontaneous ventilation in intensive care units in Latin America.

Results:

We plan to include 422 patients in ten countries. The primary outcomes are the prevalence of low tidal volume in the first 24 hours of spontaneous ventilation and ventilator-free days on day 28. The secondary outcomes are intensive care unit and hospital mortality, incidence of asynchrony and return to controlled ventilation and sedation.

Conclusion:

In this study, we will assess the prevalence of low tidal volume during spontaneous ventilation and its association with clinical outcomes, which can inform clinical practice and future clinical trials.

Keywords:
Respiratory insufficiency; Respiration, artificial; Tidal volume; Oxygen; Incidence; Prevalence; Hospital mortality; Intensive care units

Inclusion criteria
• Age > 18 years.
• Patients with hypoxemic ARF, defined as a PaO₂/FiO₂ ratio ≤ 300mmHg, under controlled invasive MV, with an expected duration of MV of at least 24 hours.
• Patients transitioned to spontaneous ventilation (PSV, PAV Plus, NAVA, CPAP and APRV).
Exclusion criteria
• Tracheostomized patients.
• Decision not to maintain or add life support measures on the day of assessment (palliative care).
• Patients in ECMO.
• Patients with an air fistula or barotrauma that prevents adequate tidal volume monitoring.
• Severe injuries to the central nervous system that result in abolished or very high respiratory drive, for whom it is not possible to maintain a protective tidal volume.

Characteristic		Value
Age (years)		xx ± x
Male, n (%)		n (xx)
BMI (kg/m²)		xx ± x
SAPS 3 score		xx ± x
SOFA		xx (xx - xx)
LIP score		xx (xx - xx)
Charlson index		xx (xx - xx)
Cause ARF
	Pneumonia (bacterial, viral, opportunistic)	n (xx)
	Extrapulmonary sepsis	n (xx)
	Coma/lowered level of consciousness	n (xx)
	Cardiogenic pulmonary edema/heart failure	n (xx)
	Aspiration	n (xx)
	Hypovolemic shock	n (xx)
	Others	n (xx)
Days of intubation prior to inclusion		xx (xx - xx)
Cause of hospitalization
	Acute respiratory failure	n (xx)
	Sepsis	n (xx)
	Neurologic diseases	n (xx)
	Postoperative monitoring	n (xx)
PaO₂/FiO₂ ratio at ARF diagnosis		xx ± x
Duration of invasive MV (days)		xx (xx - xx)
Mechanical ventilation-free days (days)		xx (xx - xx)
Duration of ICU stay (days)		xx (xx - xx)
ICU survival, n (%) [95%CI]		n (xx) (xx- xx)
Duration of hospital stay (days)		xx (xx - xx)
Hospital survival, n (%) [95%CI]		n (xx) (xx- xx)

Variable	1 hour before	1 hour after	6 hours after	12 hours after	18 hours after	24 hours after
Tidal volume (mL/kg of PBW)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
PEEP (cmH₂O)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
Respiratory rate (breaths/min)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
Ppeak, (cmH₂O)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
Minute ventilation (liters/min)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
FiO₂	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
pH	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
PaO₂ (mmHg)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
SaO₂	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
Heart rate (bpm)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
Mean arterial pressure (mmHg)	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx	xx ± xx
RASS	x (x - x)	x (x - x)	x (x - x)	x (x - x)	x (x - x)	x (x - x)
Delirium	x (x)	x (x)	x (x)	x (x)	x (x)	x (x)
Asynchrony	x (x)	x (x)	x (x)	x (x)	x (x)	x (x)
Vasopressors	x (x)	x (x)	x (x)	x (x)	x (x)	x (x)

Associação de Medicina Intensiva Brasileira - AMIB Rua Arminda, 93 - 7º andar - Vila Olímpia, CEP: 04545-100, Tel.: +55 (11) 5089-2642 - São Paulo - SP - Brazil
E-mail: ccs@amib.org.br

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[1] Corresponding author: Fabia Diniz Silva Instituto do Coração, Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo Av. Dr. Eneas de Carvalho Aguiar, 45, 5° andar, bloco 2, sala 1 Zip Code: 05403-900 - São Paulo (SP), Brazil E-mail: fabiadinizslv@gmail.com