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

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ClinicalTrials.gov Identifier: NCT02715674
Recruitment Status : Unknown
Verified March 2016 by HULYA KAHRAMAN SAH, Istanbul University.
Recruitment status was:  Recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
HULYA KAHRAMAN SAH, 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)

Condition or disease Intervention/treatment Phase
Neoplasms, Intracranial Device: Plasti-med TRIFLO Device: BIPAP VISION Device: Plasti-med oxygen therapy mask Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
Study Start Date : June 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Placebo Comparator: control group
take 4lt/min oxygen with Plasti-med oxygen therapy mask
Device: Plasti-med oxygen therapy mask
Active Comparator: IS group
in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours.
Device: Plasti-med TRIFLO
Active Comparator: CPAP group
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



Primary Outcome Measures :
  1. Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Spirolab 3 COLOUR LCD device for measurement.


Secondary Outcome Measures :
  1. Change from baseline forced vital capacity (FVC) % predicted (no unit) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Spirolab 3 COLOUR LCD device for measurement.

  2. Change from baseline FEV1/FVC ratio (no units) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Spirolab 3 COLOUR LCD device for measurement.

  3. Change from baseline partial arterial oxygen pressure( PaO2) (mmHg) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  4. Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  5. Change from baseline power of hydrogen (pH) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  6. Change from baseline arterial oxygen saturation (SaO2) (%) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  7. Change from baseline base excess (BE) (mmol/L) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  8. Change from baseline bicarbonate (HCO3) (mmol/L) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will use Cobas B 221 device for measurement.

  9. Change from baseline PaO2/FiO2 ratio (no units) [ Time Frame: preoperative baseline, postoperative 1st, 6th and 24th hours ]
    The investigators will calculate PaO2/FiO2 ratio



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715674


Contacts
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Contact: Hulya KAHRAMAN SAH, MD 00905064214301 drhulyakahraman@gmail.com

Locations
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Turkey
Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department Recruiting
Istanbul, Turkey, 34098
Contact: Ozlem KORKMAZ DILMEN, Asst. Prof.    00902124143000 ext 1745    korkmazdilmen@gmail.com   
Sub-Investigator: Eren F Akcil, MD         
Sub-Investigator: Yusuf Tunali, Prof.         
Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Ozlem KORKMAZ DILMEN, Asst. Prof. Istanbul University
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Responsible Party: HULYA KAHRAMAN SAH, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT02715674    
Other Study ID Numbers: 41268
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases