An interventional study of Plasti-med TRIFLO and BIPAP VISION in Neoplasms, Intracranial, sponsored by Istanbul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by Istanbul University · Not applicable and Interventional
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
take 4lt/min oxygen with Plasti-med oxygen therapy mask
Device: Plasti-med oxygen therapy mask
in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours.
Device: Plasti-med TRIFLO
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
Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit)
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
Time frame: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline forced vital capacity (FVC) % predicted (no unit)
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline PaO2/FiO2 ratio (no units)
The investigators will calculate PaO2/FiO2 ratio
Time frame: preoperative baseline, postoperative 1st, 6th and 24th hours
Plan to share: No
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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Istanbul University