Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000109101
Ethics application status
Approved
Date submitted
7/01/2019
Date registered
24/01/2019
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Date results information initially provided
24/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in the cuff pressure in newborns in the absence of nitrous oxide
Scientific title
Changes in the cuff pressure in newborns in the absence of nitrous oxide
Secondary ID [1] 296951 0
None
Universal Trial Number (UTN)
U1111-1226-1061
Trial acronym
CFN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaesthesia 310911 0
airway management 310912 0
Condition category
Condition code
Anaesthesiology 309577 309577 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
After tracheal intubation with a high volume low pressure cuffed ETT (Nextech®, Istanbul, Turkey), the cuff was inflated until there is no audible gas leak. An anaesthesiologist checked the gas leak using a stethoscope guided inflation over the trachea while holding continuous positive airway pressure of 20–25 cm H2O
The ETT cuff pressures were monitored simultaneously with a cuff manometer and pressure transducer . The measurements were observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff was deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery were recorded.
The baseline cuff pressure was assessed in the supine position after which time a second measurement was made in the prone position. A blind anesthesiologist checked and recorded the cuff pressure. If the pressure was between 10-15 cmH2O, no intervention was performed. If the pressure exceeded 15 cmH2O, the cuff pressure was managed as described above. The cuff pressures were compared over time within patients. In addition, heart rate, end-tidal CO2, temperature and peak airway pressure were recorded every 15 min.
Intervention code [1] 313224 0
Early Detection / Screening
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318532 0
the primary outcome of the study is to determine the changes in cuff pressure over time with a cuff manometer and pressure transducer
Timepoint [1] 318532 0
baseline, and over time until extubation for 75 min.
Secondary outcome [1] 365292 0
Heart rate per minute via patient monitor
Timepoint [1] 365292 0
baseline, every 15 min. for 75 min.
Secondary outcome [2] 365293 0
End-tidal CO2 via gas monitoring of anesthesia machine
Timepoint [2] 365293 0
Every 15 min. for 75 min.

Eligibility
Key inclusion criteria
Newborns
Undergoing surgery under general anesthesia
Minimum age
No limit
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients whom could not have obtained informed constent

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All data that are normally distributed were summarized as means ± standard deviation. Data that are not normally distributed were summarized as medians and 25-75th percentile. Cuff pressure and all other interval data that were measured over time were analyzed using repeated-measures ANOVA with the Tukey (or Dunnett) post-hoc test. Comparing supine and prone positions, cuff pressures were analyzed using two-way repeated measures ANOVA. Baseline demographic data was compared using unpaired t-test for normally distributed data and Mann Whitney U test for data that are not normally distributed. P<0.05 was accepted as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/08/2016
Date of last participant enrolment
Anticipated
Actual
25/09/2017
Date of last data collection
Anticipated
Actual
25/09/2017
Sample size
Target
25
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 21150 0
Turkey
State/province [1] 21150 0
Istanbul

Funding & Sponsors
Funding source category [1] 301521 0
Self funded/Unfunded
Name [1] 301521 0
Kemal Tolga Saracoglu
Country [1] 301521 0
Turkey
Primary sponsor type
Individual
Name
Kemal Tolga Saracoglu
Address
Saglik Bilimleri Universitesi Dr Lutfi Kirdar Kartal Egitim Arastirma Hastanesi Anesteziyoloji Ve Reanimasyon Klnigi Cevizli Mah. Semsi Denizer Cad. 34890 Kartal/Istanbul
Country
Turkey
Secondary sponsor category [1] 301222 0
Individual
Name [1] 301222 0
Ayten Saracoglu
Address [1] 301222 0
Marmara Universitesi Tip Fakultesi Anesteziyoloji Ve Reanimasyon Anabilim Dali Fevzi Çakmak Mahallesi, Muhsin Yazicioglu Cd No:10, 34899 Pendik/Istanbul
Country [1] 301222 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302263 0
Bilim University Ethics Committee Of Clinical Research
Ethics committee address [1] 302263 0
Bilim University Büyükdere Cad. No:120 34394 Esentepe
Sisli / Istanbul
Ethics committee country [1] 302263 0
Turkey
Date submitted for ethics approval [1] 302263 0
10/05/2016
Approval date [1] 302263 0
25/05/2016
Ethics approval number [1] 302263 0
44140529/2016-50

Summary
Brief summary
In the current study, we aim to determine the changes in cuff pressure over time in newborns undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89618 0
A/Prof Kemal Tolga Saracoglu
Address 89618 0
Health Science University Istanbul Kartal Dr. Lütfi Kirdar Egitim Ve Arastirma Hastanesi Semsi Denizer Cad. E-5 Üzeri Cevizli Mevkii 34890 Kartal/Istanbul
Country 89618 0
Turkey
Phone 89618 0
+905385478620
Fax 89618 0
Email 89618 0
[email protected]
Contact person for public queries
Name 89619 0
A/Prof Kemal Tolga Saracoglu
Address 89619 0
Health Science University Istanbul Kartal Dr. Lütfi Kirdar Egitim Ve Arastirma Hastanesi Semsi Denizer Cad. E-5 Üzeri Cevizli Mevkii 34890 Kartal/Istanbul
Country 89619 0
Turkey
Phone 89619 0
+905385478620
Fax 89619 0
Email 89619 0
[email protected]
Contact person for scientific queries
Name 89620 0
A/Prof Kemal Tolga Saracoglu
Address 89620 0
Health Science University Istanbul Kartal Dr. Lütfi Kirdar Egitim Ve Arastirma Hastanesi Semsi Denizer Cad. E-5 Üzeri Cevizli Mevkii 34890 Kartal/Istanbul
Country 89620 0
Turkey
Phone 89620 0
+905385478620
Fax 89620 0
Email 89620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChanges in the cuff pressure in neonates in the absence of nitrous oxide.2022https://dx.doi.org/10.5114/ait.2022.114485
N.B. These documents automatically identified may not have been verified by the study sponsor.