Elsevier

The Lancet

Volume 374, Issue 9695, 26 September–2 October 2009, Pages 1082-1088
The Lancet

Articles
Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial

https://doi.org/10.1016/S0140-6736(09)61038-2Get rights and content

Summary

Background

Non-invasive ventilation can prevent respiratory failure after extubation in individuals at increased risk of this complication, and enhanced survival in patients with hypercapnia has been recorded. We aimed to assess prospectively the effectiveness of non-invasive ventilation after extubation in patients with hypercapnia and as rescue therapy when respiratory failure develops.

Methods

We undertook a randomised controlled trial in three intensive-care units in Spain. We enrolled 106 mechanically ventilated patients with chronic respiratory disorders and hypercapnia after a successful spontaneous breathing trial. We randomly allocated participants by computer to receive after extubation either non-invasive ventilation for 24 h (n=54) or conventional oxygen treatment (n=52). The primary endpoint was avoidance of respiratory failure within 72 h after extubation. Analysis was by intention to treat. This trial is registered with clinicaltrials.gov, identifier NCT00539708.

Findings

Respiratory failure after extubation was less frequent in patients assigned non-invasive ventilation than in those allocated conventional oxygen therapy (8 [15%] vs 25 [48%]; odds ratio 5·32 [95% CI 2·11–13·46]; p<0·0001). In patients with respiratory failure, non-invasive ventilation as rescue therapy avoided reintubation in 17 of 27 patients. Non-invasive ventilation was independently associated with a lower risk of respiratory failure after extubation (adjusted odds ratio 0·17 [95% CI 0·06–0·44]; p<0·0001). 90-day mortality was lower in patients assigned non-invasive ventilation than in those allocated conventional oxygen (p=0·0146).

Interpretation

Early non-invasive ventilation after extubation diminished risk of respiratory failure and lowered 90-day mortality in patients with hypercapnia during a spontaneous breathing trial. Routine implementation of this strategy for management of mechanically ventilated patients with chronic respiratory disorders is advisable.

Funding

IDIBAPS, CibeRes, Fondo de Investigaciones Sanitarias, European Respiratory Society.

Introduction

Reintubation is sometimes necessary for management of respiratory failure after extubation1 and is undertaken in 6–23% of patients within 48–72 h of planned extubation.2, 3, 4 Although reintubation could indicate increased disease severity, it is an independent risk factor for nosocomial pneumonia,5 mortality, and extended hospital stay.2

Findings of a case-control study6 suggest that non-invasive ventilation could be a promising treatment for respiratory failure after extubation, with potential to avoid reintubation.7 However, some concerns have been raised about use of non-invasive ventilation because in two randomised clinical trials in mixed populations, non-invasive ventilation was not beneficial in decreasing the risk of reintubation for patients who developed respiratory failure after extubation.1, 8 By contrast, non-invasive ventilation implemented immediately after planned extubation was effective at avoiding respiratory failure in people at high risk of this complication who had tolerated a spontaneous breathing trial.9, 10 Subgroup analysis showed that the benefits of non-invasive ventilation at enhancing survival were restricted to patients with hypercapnia (partial pressure of arterial carbon dioxide [PaCO2] >45 mm Hg) during the spontaneous breathing trial before extubation.10 In this subset of patients, 98% had underlying chronic respiratory disorders.

Findings of an adequately powered clinical trial should be able to show benefits of non-invasive ventilation after extubation in a hypercapnic population for several reasons. First, definitive conclusions can be drawn, unlike with subgroup analyses. Second, the numbers of patients with hypercapnia enrolled into the study can be controlled, by comparison with low numbers recorded in previous subgroup analyses.10 Finally, non-invasive ventilation is an effective treatment for patients with acute-on-chronic hypercapnic respiratory failure.11

We postulated that early use of non-invasive ventilation during the initial period after extubation would avert respiratory failure and enhance survival of patients with chronic respiratory disorders who had hypercapnia during a spontaneous breathing trial before extubation. Therefore, we aimed to assess the effectiveness of this strategy compared with conventional oxygen management in patients who underwent planned extubation.

Section snippets

Patients

We undertook a randomised controlled trial in the respiratory and medical intensive-care units of Hospital Clinic, Barcelona, and in the general intensive-care unit of Hospital Morales Meseguer, Murcia, Spain. All patients with chronic respiratory disorders, intubated for 48 h or more, who tolerated a spontaneous breathing trial through a T-piece after recovery of their disease, with hypercapnic respiratory failure (PaCO2 >45 mm Hg) on spontaneous breathing, were deemed eligible for the study.

Results

Between May, 2005, and December, 2007, 164 consecutive patients were registered for the study, of whom 106 underwent random allocation (figure 1). 54 were allocated non-invasive ventilation and 52 were assigned control. General clinical characteristics and physiological variables of patients at entry into the study did not differ at baseline (Table 1, Table 2).

Non-invasive ventilation was delivered for a mean period of 18 h (SD 7) in patients assigned to this group. Mean levels of inspiratory

Discussion

The results of our study confirm the benefits of early use of non-invasive ventilation after extubation to diminish risk of respiratory failure in patients with chronic respiratory disorders and hypercapnia during a spontaneous breathing trial. This strategy resulted in lowered mortality in our population.

This specific population is at high risk of development of respiratory failure after extubation, confirmed by a frequency of 48% in the control group, similar to a 41% rate recorded in a

References (30)

  • SK Epstein et al.

    Effect of failed extubation on the outcome of mechanical ventilation

    Chest

    (1997)
  • PK Plant et al.

    Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial

    Lancet

    (2000)
  • A Esteban et al.

    Noninvasive positive-pressure ventilation for respiratory failure after extubation

    N Engl J Med

    (2004)
  • A Esteban et al.

    Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation

    Am J Respir Crit Care Med

    (1999)
  • SK Epstein

    Decision to extubate

    Intensive Care Med

    (2002)
  • A Torres et al.

    Re-intubation increases the risk of nosocomial pneumonia in patients needing mechanical ventilation

    Am J Respir Crit Care Med

    (1995)
  • G Hilbert et al.

    Noninvasive pressure support ventilation in COPD patients with postextubation hypercapnic respiratory insufficiency

    Eur Respir J

    (1998)
  • International Consensus Conferences in Intensive Care Medicine: noninvasive positive pressure ventilation in acute respiratory failure

    Am J Respir Crit Care Med

    (2001)
  • SP Keenan et al.

    Noninvasive positive-pressure ventilation for postextubation respiratory distress: a randomized controlled trial

    JAMA

    (2002)
  • S Nava et al.

    Noninvasive ventilation to prevent respiratory failure after extubation in high-risk patients

    Crit Care Med

    (2005)
  • M Ferrer et al.

    Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial

    Am J Respir Crit Care Med

    (2006)
  • JV Lightowler et al.

    Non-invasive positive pressure ventilation to treat respiratory failure resulting from exacerbations of chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis

    BMJ

    (2003)
  • M Ferrer et al.

    Noninvasive ventilation during persistent weaning failure: a randomized controlled trial

    Am J Respir Crit Care Med

    (2003)
  • SK Epstein et al.

    Independent effects of etiology of failure and time of reintubation on outcome for patients failing extubation

    Am J Respir Crit Care Med

    (1998)
  • PK Plant et al.

    Non-invasive ventilation in acute exacerbations of chronic obstructive pulmonary disease: long term survival and predictors of in-hospital outcome

    Thorax

    (2001)
  • Cited by (0)

    View full text