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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | take 4lt/min oxygen with Plasti-med oxygen therapy mask |
|
| IS group | Active Comparator | in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours. |
|
| CPAP group | Active Comparator | in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasti-med TRIFLO | Device |
| ||
| BIPAP VISION |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit) | The investigators will use Spirolab 3 COLOUR LCD device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline forced vital capacity (FVC) % predicted (no unit) | The investigators will use Spirolab 3 COLOUR LCD device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline FEV1/FVC ratio (no units) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hulya KAHRAMAN SAH, MD | Contact | 00905064214301 | drhulyakahraman@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ozlem KORKMAZ DILMEN, Asst. Prof. | Istanbul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
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|
| Plasti-med oxygen therapy mask | Device |
|
The investigators will use Spirolab 3 COLOUR LCD device for measurement. |
| preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline partial arterial oxygen pressure( PaO2) (mmHg) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline power of hydrogen (pH) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline arterial oxygen saturation (SaO2) (%) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline base excess (BE) (mmol/L) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline bicarbonate (HCO3) (mmol/L) | The investigators will use Cobas B 221 device for measurement. | preoperative baseline, postoperative 1st, 6th and 24th hours |
| Change from baseline PaO2/FiO2 ratio (no units) | The investigators will calculate PaO2/FiO2 ratio | preoperative baseline, postoperative 1st, 6th and 24th hours |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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