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Randomized Controlled Trial
. 2021 Apr;159(4):1426-1436.
doi: 10.1016/j.chest.2020.10.079. Epub 2020 Nov 13.

Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial

Tommaso Mauri  1 , Giuseppe Foti  2 , Carla Fornari  3 , Giacomo Grasselli  4 , Riccardo Pinciroli  5 , Federica Lovisari  6 , Daniela Tubiolo  7 , Carlo Alberto Volta  8 , Savino Spadaro  8 , Roberto Rona  9 , Egle Rondelli  9 , Paolo Navalesi  10 , Eugenio Garofalo  11 , Rihard Knafelj  12 , Vojka Gorjup  12 , Riccardo Colombo  13 , Andrea Cortegiani  14 , Jian-Xin Zhou  15 , Rocco D'Andrea  16 , Italo Calamai  17 , Ánxela Vidal González  18 , Oriol Roca  19 , Domenico Luca Grieco  20 , Tomas Jovaisa  21 , Dimitrios Bampalis  22 , Tobias Becher  23 , Denise Battaglini  24 , Huiqing Ge  25 , Mariana Luz  26 , Jean-Michel Constantin  27 , Marco Ranieri  16 , Claude Guerin  28 , Jordi Mancebo  29 , Paolo Pelosi  24 , Roberto Fumagalli  5 , Laurent Brochard  30 , Antonio Pesenti  4 ; PROTECTION Trial Collaborators
Collaborators, Affiliations
Randomized Controlled Trial

Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial

Tommaso Mauri et al. Chest. 2021 Apr.

Abstract

Background: Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant.

Research question: Is the clinical application of sigh during pressure support ventilation (PSV) feasible?

Study design and methods: We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm H2O for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days.

Results: Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, -7%; 95% CI, -18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group.

Interpretation: Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.

Trial registry: ClinicalTrials.gov; No.: NCT03201263; URL: www.clinicaltrials.gov.

Keywords: ARDS; feasibility; pressure support; sigh; ventilation.

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Figures

Figure 1
Figure 1
Flow of patients in the trial. PEEP = positive end-expiratory pressure; PSV = pressure support ventilation.
Figure 2
Figure 2
Treatment difference for failure of assisted ventilation between study groups. Dot and error bars indicate absolute value and two-sided 95% CIs, respectively. The maximum tolerance accepted in this noninferiority randomized clinical trial was 5% (light blue dotted line).
Figure 3
Figure 3
Twenty-eight-day mortality in the study groups.
See this image and copyright information in PMC

References

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