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

Istanbul University

Status: Unknown

Conditions: Neoplasms, Intracranial

Treatments: Device: Plasti-med oxygen therapy mask; Device: Plasti-med TRIFLO; Device: BIPAP VISION

Study type: Interventional

Funder types: Other

Identifiers

NCT02715674

41268

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

take 4lt/min oxygen with Plasti-med oxygen therapy mask

Treatment:

Device: Plasti-med oxygen therapy mask

IS group

Active Comparator group

Description:

in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours.

Treatment:

Device: Plasti-med TRIFLO

CPAP group

Active Comparator group

Description:

in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours.

Treatment:

Device: BIPAP VISION