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

March 21, 2016 updated by: HULYA KAHRAMAN SAH, Istanbul University
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department
        • Contact:
        • Sub-Investigator:
          • Eren F Akcil, MD
        • Sub-Investigator:
          • Yusuf Tunali, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
preoperative baseline, postoperative 1st, 6th and 24th hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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.
preoperative baseline, postoperative 1st, 6th and 24th hours
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
preoperative baseline, postoperative 1st, 6th and 24th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Ozlem KORKMAZ DILMEN, Asst. Prof., Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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