Neoplasms, Intracranial
Conditions
Brief summary
This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20)
Detailed description
This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20). The investigators included male or female, between 18 and 60 years old, American Society of Anesthesiologists score 1, 2 patients in this study. The investigator excluded patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation from this study. In postoperatively, control group will take 4lt/min oxygen with Plasti-med oxygen therapy mask for 6 hours, IS group will carry out Plasti-med TRIFLO 5 min per hour for 6 hours, CPAP group will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. Lung functions and arterial blood gas analysis will be recorded preoperative baseline, postoperative 1st, 6th and 24th hours.
Interventions
DEVICEPlasti-med TRIFLO
DEVICEBIPAP VISION
DEVICEPlasti-med oxygen therapy mask
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists score 1, 2 patients
Exclusion criteria
* Patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Spirolab 3 COLOUR LCD device for measurement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline forced vital capacity (FVC) % predicted (no unit) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Spirolab 3 COLOUR LCD device for measurement. |
| Change from baseline FEV1/FVC ratio (no units) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Spirolab 3 COLOUR LCD device for measurement. |
| Change from baseline partial arterial oxygen pressure( PaO2) (mmHg) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
| Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
| Change from baseline base excess (BE) (mmol/L) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
| Change from baseline arterial oxygen saturation (SaO2) (%) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
| Change from baseline bicarbonate (HCO3) (mmol/L) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
| Change from baseline PaO2/FiO2 ratio (no units) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will calculate PaO2/FiO2 ratio |
| Change from baseline power of hydrogen (pH) | preoperative baseline, postoperative 1st, 6th and 24th hours | The investigators will use Cobas B 221 device for measurement. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactHulya KAHRAMAN SAH, MD
Outcome results
None listed