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

Neoplasms, Intracranial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02715674
• Other study ID #: 41268
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: March 21, 2016
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2016
• Source: Istanbul University
• Contact: Hulya KAHRAMAN SAH, MD
• Phone: 00905064214301
• Email: drhulyakahraman[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasms, Intracranial

Intervention

Device:
• Plasti-med TRIFLO

• BIPAP VISION

• Plasti-med oxygen therapy mask

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline PaO2/FiO2 ratio (no units)	The investigators will calculate PaO2/FiO2 ratio	preoperative baseline, postoperative 1st, 6th and 24th hours	No