postoperative atelectasis / pneumonias MedDRA version: 16.0 Level: LLT Classification code 10069454 Term: Partial atelectasis System Organ Class: 100000004855
Conditions
Interventions
Product Name: AIRE MEDICINAL SINTETICO gas para inhalación
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: OXYGEN
Other descriptive name: oxigen/air
Concentration unit: l litre(s)
Concentr
Sponsors
Fundación para la Investigación Biomédica del Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Being over 18 and ethically competent. 2)Undergo any thoracic surgery including resection of lung parenchyma and carriers of thoracic epidural or paravertebral catheter for perioperative thoracic analgesia. 3)To have given written consent to enter this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: 1)Patients who have not been extubated in the first 4 h post surgery. 2)Patients with suspected bronchopleural fistula at PCU admission . 3)Patients with facial problems or patients with a history of intolerance to CPAP masks. 4)Having significant bullous emphysema. 5)Patients having Obstructive apnea syndrome and have been recomended of any kind of noninvasive ventilation. 6)Patients who have consumed at least one month before surgery potential immunosuppressive drugs (except corticosteroids administered by inhalation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of CPAP at 5-7 cmH2O vs standard treatment on the frequency of atelectasis/pneumonia, as determined by clinical and radiographic criteria, in patients undergoing Lung resection surgery and no more than 4 hours of postoperative mechanical ventilation.;Secondary Objective: 1)compare the frequencies of patients with a PaO2/FiO2 <300 with CPAP at 5-7 cmH2O vs standard treatment the morning following the surgical procedure on patients .2) compare the frequencies of patients presenting persistent air leak with CPAP at 7 cmH2O vs standard treatment on patients .3)To compare the frequencies of patients presenting any pulmonary or cardiac complications with CPAP at 5-7 cmH2O vs standard treatment.4) compare the effects of CPAP at 5-7 cmH2O vs standard treatment in the hospital stay from the day of surgery until hospital discharge on patients.5)compare frecuency of patients on CPAP at 5-7 cmH2O group vs standard treatment staying more than one day in the postanesthesic care unit.;Primary end point(s): the frequency of atelectasis/pneumonia by the intervention (CPAP at 5-7 cmH2O, 6h) vs the active comparator(standard treatment), as determined by clinical and radiographic criteria, in patients undergoing lung resection surgery and no more than 4 h of postoperative mechanical ventilation.;Timepoint(s) of evaluation of this end point: 24 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): treatment, as determined by arterial blood gas analysis and the FiO2 supplied by the Ventura mask.2)significative difference betweene frequencies of patients with a PaO2/FiO2 <300 with CPAP at 5-7 cmH2O vs standard treatment the morning following the surgical procedure .3)A difference of a day hospital stay from the day of surgery until discharge between the two groups. 4) Compare the proportion of patients requiring more than one day of admission at PACU between two groups . 5)Frequencies of patients presenting persistent air leak in the two groups.6)Frequencies of patients presenting any pulmonary or cardiac complications .;Timepoint(s) of evaluation of this end point: 1) 24 hours after extubation 2) the morning following the surgical procedure 3)at hospital discharge or exitus 4) at PACU or discharge(or exitus in PACU) 5)at hospital discharge 6) 30 days after surgery | — |
Countries
Spain
Contacts
Public Contactresponsable ucaicec
Fundación para la Investigación Biomédica del Hospital
Outcome results
None listed