Neoplasms, IntracranialNCT02715674
Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
A study testing Plasti-med TRIFLO, BIPAP VISION and Plasti-med oxygen therapy mask in people with Neoplasms, Intracranial, run by Istanbul University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Intracranial
- What is being tested?
- Plasti-med TRIFLO, BIPAP VISION and Plasti-med oxygen therapy mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists score 1, 2 patients
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department
Istanbul, 34098
Ozlem KORKMAZ DILMEN, Asst. Prof., 00902124143000 ext. 1745, korkmazdilmen@gmail.com
Eren F Akcil, MD
About this study
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)
Read the 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.
- Conditions
- Neoplasms, Intracranial
- Being tested
- Plasti-med TRIFLO, BIPAP VISION, Plasti-med oxygen therapy mask
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasti-med TRIFLODevice
BIPAP VISIONDevice
Plasti-med oxygen therapy maskDevice
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | take 4lt/min oxygen with Plasti-med oxygen therapy mask Receives: Device: Plasti-med oxygen therapy mask |
| IS group | Active comparator | in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours. Receives: Device: Plasti-med TRIFLO |
| CPAP group | Active comparator | in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. Receives: Device: BIPAP VISION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit)
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Secondary outcomes (9)
Change from baseline forced vital capacity (FVC) % predicted (no unit)
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline FEV1/FVC ratio (no units)
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline partial arterial oxygen pressure( PaO2) (mmHg)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline power of hydrogen (pH)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline arterial oxygen saturation (SaO2) (%)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline base excess (BE) (mmol/L)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline bicarbonate (HCO3) (mmol/L)
The investigators will use Cobas B 221 device for measurement.
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Change from baseline PaO2/FiO2 ratio (no units)
The investigators will calculate PaO2/FiO2 ratio
Measured: preoperative baseline, postoperative 1st, 6th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, IntracranialStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HULYA KAHRAMAN SAH, Istanbul University
- Investigators
- Ozlem KORKMAZ DILMEN, Asst. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715674
- Sponsor's protocol ID
- 41268
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
- ClinicalTrials.gov ID
- NCT02715674
- Acronym / sponsor ID
- 41268
- Conditions
- Neoplasms, Intracranial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: Plasti-med oxygen therapy masktake 4lt/min oxygen with Plasti-med oxygen therapy mask |
| IS group | Active comparator | Device: Plasti-med TRIFLOin postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours. |
| CPAP group | Active comparator | Device: BIPAP VISIONin postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists score 1, 2 patients
Key exclusion criteria (1 listed)
- Patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasti-med TRIFLO | Device | IS group |
| BIPAP VISION | Device | CPAP group |
| Plasti-med oxygen therapy mask | Device | control group |
Primary outcome
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.
9 secondary outcomes
Change from baseline forced vital capacity (FVC) % predicted (no unit)
Time frame: 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
Change from baseline partial arterial oxygen pressure( PaO2) (mmHg)
Time frame: 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
Change from baseline power of hydrogen (pH)
Time frame: 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
Change from baseline base excess (BE) (mmol/L)
Time frame: 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
Change from baseline PaO2/FiO2 ratio (no units)
Time frame: preoperative baseline, postoperative 1st, 6th and 24th hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem KORKMAZ DILMEN, Asst. Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasti-med TRIFLO, BIPAP VISION and Plasti-med oxygen therapy mask in people with Neoplasms, Intracranial, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hulya KAHRAMAN SAH, MD (00905064214301, drhulyakahraman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit) (time frame: preoperative baseline, postoperative 1st, 6th and 24th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.