Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy

Study Overview
=================
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.

Official Title
-----------------
Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy

Conditions
-----------------
Neoplasms, Intracranial

Intervention / Treatment
-----------------
* Device: Plasti-med TRIFLO
* Device: BIPAP VISION
* Device: Plasti-med oxygen therapy mask


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>take 4lt/min oxygen with Plasti-med oxygen therapy mask | Device: Plasti-med oxygen therapy mask<br> <br> |
| Active Comparator: IS group<br>in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours. | Device: Plasti-med TRIFLO<br> <br> |
| Active Comparator: CPAP group<br>in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. | Device: BIPAP VISION<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |