Respiratory Failure Clinical Trial
Official title:
Non-Invasive Mechanical Ventilation Versus Oxygen Therapy in Patients With Acute Respiratory Failure After Extubation in a Intensive Care Unit
Non-invasive mechanical ventilation (NIV) has not exhibited a reduction of reintubation after
extubation failure compared to oxygen therapy. The reduction of reintubation with NIV versus
oxygen therapy in patients with extubation failure was evaluated.
A clinical trial was conducted that included patients who underwent mechanical ventilation
and developed acute respiratory failure after extubation. After extubation failure,
thirty-three were assigned to NIV and thirty-two were assigned to oxygen therapy.
Patients. Medical and surgical patients admitted to intensive care unit with 18 years of age
or older in weaning from their first episode of mechanical ventilation for more than 24 hours
were included. Patients with structural neurological disorder, acute toxic-metabolic
neurological encephalopathy with neurological deficit [estimated by a Glasgow Coma Score <14
points] at the time of weaning, neuromuscular disease, chronic obstructive pulmonary disease
receiving non-invasive ventilation, limitation of life support therapy during their
admission, tracheostomized patients, spinal cord injuries, scheduled surgical procedure
during the 48 hours following extubation, intensive care unit readmission, transfer to
another centre or a contraindication to non-invasive ventilation were excluded.
Weaning protocol. The beginning of weaning was considered when patients were conscious,
without pain, connected to mechanical ventilation in pressure support ventilation mode,
fraction of inspired oxygen ≤0.5, positive end-expiratory pressure +5cmH20, dopamine ≤5
mcgr/kg/min or noradrenaline ≤0.2 mcgr/kg/min, temperature <38ºC and absence of metabolic
acidosis. Weaning consisted of a spontaneous breathing trial, which is routinely performed in
our unit with a T-tube connected to an oxygen source . The following conditions indicated a
successful spontaneous breathing trial: oxygen partial pressure ≥60 mmHg or transcutaneous
oxygen saturation>90% with fraction of inspired oxygen <0.5, carbon dioxide partial pressure
<50 mmHg (or an increase <8 mmHg), pH >7.32, respiratory rate <35 bpm (or an increase <50%),
heart rate <140 bpm (or an increase <20%), systolic blood pressure <180 mmHg, and absence of
cardiac arrhythmias after a minimum period of 30-120 min. Once the test was completed,
extubation and subsequent placement of a Venturi oxygen mask with 0.3-0.4 fraction of
inspired oxygen was performed. The physician in charge was responsible for the process of
removal of mechanical ventilation and subsequent extubation. In the case of T-tube test
failure, the patient was reconnected to the ventilator. Patient who presented clinical
deterioration within 48 hours after extubation (work of breathing, use of accessory muscles,
paradoxical breathing) and/or respiratory-gasometric deterioration [respiratory rate >25 bpm
or increase of >50% with respect to the baseline respiratory rate, oxygen partial pressure
<65 mmHg, carbon dioxide partial pressure >45 mmHg or pH <7.33) [19] and who were candidates
for non-invasive ventilation were included in the study. Extubation failure was classified as
follows: 1) Acute respiratory failure secondary to airway problems: obstruction of the upper
airway and aspiration or excess of secretions; 2) Acute respiratory failure not dependent of
the airway: acute pulmonary oedema, congestive heart failure, hypoxemic and/or hypercapnic
acute respiratory failure, encephalopathy and others (digestive bleeding, shock, etc.).
Patients who required immediate reintubation after extubation failure were not included.
After confirming extubation failure and the possibility of eligibility to participate in the
study, the patient was assigned to a group (non-invasive ventilation group or oxygen group)
through the opening of a sealed envelope. Previously, a simple randomisation by a
computerised system had been performed by a physician not involved in the study.
Non-invasive ventilation. BiPAP Vision and continuous positive airway pressure devices were
used. For the BiPAP Vision, oronasal and facial masks and an active humidification system
were used. Procedure: Once the patient was informed of the procedure, the type of mask was
selected according to the clinical situation and anatomy of the patient, and the harness was
placed. Ventilation was initiated with progressive levels of inspiratory positive airway
pressure and expiratory positive airway pressure until a minimum inspiratory positive airway
pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved
in the first hour. The rise time was 0.1-0.2 seconds. Continuous positive airway pressure. A
continuous positive airway pressure device was used through the oronasal mask on the patient.
The minimum initial positive end-expiratory pressure level was 5 cmH2O, with progressive
increases up to 10-15 cmH2O. The objective pressures of both devices were set to reduce
dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. The
fraction of inspired oxygen was increased in both devices until a transcutaneous oxygen
saturation of 94-96% was achieved. Once the patient's cooperation and sufficient adaptability
were achieved, the mask was adjusted to the harness with adjustable straps.
Oxygen therapy. The control group received oxygen therapy using a Venturi mask with an
fraction of inspired oxygen up to 0.5 or using a reservoir mask connected to a high-flow
flowmeter with 30 L/min of O2 (estimated fraction of inspired oxygen of 1.0).
Both non-invasive ventilation/continuous positive airway pressure and oxygen therapy were
maintained continuously (except for hygiene or oral intake) until the patient exhibited
improvement from the clinical and/or gasometric perspective. Withdrawal of non-invasive
ventilation/continuous positive airway pressure was performed progressively with reduction of
inspiratory airway pressure/expiratory positive airway pressure or positive end-expiratory
pressure levels until complete disconnection of non-invasive ventilation. In both groups
(study and control), after improvement, the fraction of inspired oxygen of the Venturi mask
was set to 0.3-0.4. The criteria for failure of both non-invasive ventilation and oxygen
therapy were: absence of clinical improvement (respiratory rate>35 bpm, use of accessory
muscles, thoracoabdominal asynchrony, encephalopathy) or deterioration of oxygenation
(decrease in oxygen partial pressure or in oxygen partial pressure to fraction of inspired
oxygen ratio), haemodynamic (noradrenaline >0.5 mcgr/kg/min) or ventilation (increase in
carbon dioxide partial pressure and decrease in pH) parameters. Modifications of fraction of
inspired oxygen and inspiratory positive airway pressure/expiratory positive airway pressure
or positive end-expiratory pressure levels, as well as the time of orotracheal intubation
were performed according to the criteria of the physician. All patients received aspiration
of secretions, postural changes, incentive spirometry and bronchodilators.
Parameters analysed. After inclusion in the study, demographic data, the reason of mechanical
ventilation, severity according to the Simplified Acute Physiology Score 3, organ failure
according to the Sequential Organ Failure Assessment scale (both of them at intensive care
unit admission) and comorbidities were recorded. The duration both of mechanical ventilation
until the first extubation and time of spontaneous breathing trial were measured.
Neurological variables (Glasgow Coma Score), haemodynamic variables [systolic blood pressure,
diastolic blood pressure, mean blood pressure, heart rate], respiratory variables
(respiratory rate, transcutaneous oxygen saturation) and blood gases (oxygen partial
pressure, fraction of inspired oxygen, oxygen partial pressure to fraction of inspired oxygen
ratio, carbon dioxide partial pressure, pH, bicarbonate and lactic acid) were recorded during
the T-test of patients eligible to participate in the study and later, when they presented
acute respiratory failure due to extubation failure. Similarly, ventilatory parameters were
recorded during the 1st,2nd, and 8th hours of randomisation. Time from extubation to acute
respiratory failure extubation failure was recorded. After extubation failure, the following
variables were recorded: reintubation, tracheostomy, organ failure (cardiovascular,
coagulation, renal, liver, neurological) using the Sequential Organ Failure Assessment scale
and infectious complications (pneumonia or tracheobronchitis associated to mechanical
ventilation, urinary tract infection, bacteraemia) were determined. Also the duration both of
non-invasive ventilation. and oxygen therapy and globally of mechanical ventilation, were
calculated. The mortality rates in the intensive care unit, in the hospital, and at 90 days
were determined.
Sample size. Based on previous results, it was considered that the need for intubation could
be reduced by 35%. The estimated sample size was 30 patients in each group [NIV group vs
oxygen therapy] with a confidence interval [1-α] of 95% and power [1-β] of 80%. Comparative
analyses were conducted using Student's t test or the Mann-Whitney test for the comparisons
of quantitative variables for parametric and non-parametric characteristics, respectively.
For qualitative variables, chi-square statistic or Fisher's exact test were used. Differences
were considered significant if P <0.05. A per protocol analysis was performed. Multivariate
analysis for repeated measures (with Bonferroni's correction) was performed with the aim of
studying the influence either of NIV or oxygen therapy on respiratory parameters. The
cumulative probability of survival was assessed using a Kaplan-Meier estimation of survival
and a log-rank test to compare the two groups. The data were analysed using the statistical
package SPSS 20.0.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04030208 -
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
|
N/A | |
Recruiting |
NCT04668313 -
COVID-19 Advanced Respiratory Physiology (CARP) Study
|
||
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04505592 -
Tenecteplase in Patients With COVID-19
|
Phase 2 | |
Completed |
NCT03943914 -
Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
|
N/A | |
Active, not recruiting |
NCT03472768 -
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02265198 -
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT01659268 -
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
Terminated |
NCT01333059 -
Cycling of Sedative Infusions in Critically Ill Pediatric Patients
|
N/A | |
Completed |
NCT01249794 -
Non Invasive Ventilation After Cardiac Surgery
|
N/A |