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

Not Applicable

• Conditions: Neoplasms, Intracranial
• Interventions: Device: BIPAP VISION; Device: Plasti-med oxygen therapy mask; Device: Plasti-med TRIFLO

• Registration Number: NCT02715674
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-02-23
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP group	BIPAP VISION	in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours.
control group	Plasti-med oxygen therapy mask	take 4lt/min oxygen with Plasti-med oxygen therapy mask
IS group	Plasti-med TRIFLO	in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 power of hydrogen (pH)	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 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 PaO2/FiO2 ratio (no units)	preoperative baseline, postoperative 1st, 6th and 24th hours	The investigators will calculate PaO2/FiO2 ratio

Trial Locations

Locations (1)

Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department; 🇹🇷 Istanbul, Turkey