NCT02715674

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.4 years

First QC Date

February 23, 2016

Last Update Submit

March 21, 2016

Conditions

Neoplasms, Intracranial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Change from baseline forced vital capacity (FVC) % predicted (no unit)

    preoperative baseline, postoperative 1st, 6th and 24th hours

  • Change from baseline FEV1/FVC ratio (no units)

    preoperative baseline, postoperative 1st, 6th and 24th hours

  • Change from baseline partial arterial oxygen pressure( PaO2) (mmHg)

    preoperative baseline, postoperative 1st, 6th and 24th hours

  • Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg)

    preoperative baseline, postoperative 1st, 6th and 24th hours

  • Change from baseline power of hydrogen (pH)

    preoperative baseline, postoperative 1st, 6th and 24th hours

  • +4 more secondary outcomes

Study Arms (3)

control group

PLACEBO COMPARATOR

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

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.

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.

Device: BIPAP VISION

Interventions

Plasti-med TRIFLODEVICE
IS group
BIPAP VISIONDEVICE
CPAP group
Plasti-med oxygen therapy maskDEVICE
control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists score 1, 2 patients

You may not qualify if:

  • Patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ozlem KORKMAZ DILMEN, Asst. Prof.

    Istanbul University

    STUDY DIRECTOR

Central Study Contacts

Hulya KAHRAMAN SAH, MD

CONTACT

00905064214301drhulyakahraman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 22, 2016

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 22, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)