Clinical trial NCT02715674: Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
Official title: Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms, Intracranial
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
Secondary outcomes:
measure: Change from baseline forced vital capacity (FVC) % predicted (no unit)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline FEV1/FVC ratio (no units)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline partial arterial oxygen pressure( PaO2) (mmHg)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline power of hydrogen (pH)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline arterial oxygen saturation (SaO2) (%)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline base excess (BE) (mmol/L)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline bicarbonate (HCO3) (mmol/L)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
measure: Change from baseline PaO2/FiO2 ratio (no units)
timeFrame: preoperative baseline, postoperative 1st, 6th and 24th hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department
Study officials:
affiliation: Istanbul University
name: Ozlem KORKMAZ DILMEN, Asst. Prof.
role: STUDY_DIRECTOR
References: