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Trial registered on ANZCTR


Registration number
ACTRN12618000902291
Ethics application status
Approved
Date submitted
27/05/2018
Date registered
29/05/2018
Date last updated
8/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does video laryngoscopy administration ease the intubation in patients undergoing cesarean section ?
Scientific title
Comparison of the McGrath Video Laryngoscope and Macintosh Direct Laryngoscope on intubation times and glottic view assessment in Obstetric Patients: A Randomized Controlled Trial
Secondary ID [1] 295007 0
none
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 308026 0
cesarean section 308027 0
childbirth 308046 0
Condition category
Condition code
Anaesthesiology 307062 307062 0 0
Other anaesthesiology
Reproductive Health and Childbirth 307063 307063 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we are using an airway approach for patients undergoing cesarean section under general anesthesia. After the patient arrive in the OR, the ASA standard monitoring procedures will be applied. All the patients will receive standard general anesthetic regimens, which include propofol [intravenous (IV), 1–2 mg/kg titrations] and rocuronium bromide (IV, 0.6 mg/kg). The timing measurements will begin once the McGrath video laryngoscope blade will be placed in 1 or 2 seconds in the patient’s mouth by the attending researcher anesthesiologist, and they will end when an end-tidal CO2 trace will be detected on the direct supervision by researcher. The attending anesthesiologist will rate the glottic visualization as the tracheal tube being inserted using the Cormack-Lehane classification system and the percentage of glottic opening (POGO)
Intervention code [1] 301342 0
Treatment: Devices
Comparator / control treatment
Patients in group Macintosh direct laryngoscopy (control, the timing measurements will begin once the Macintosh direct laryngoscope blade will be placed in the patient’s mouth, and they will end when an end-tidal CO2 trace will be detected. The attending anesthesiologist will rate the glottic visualization as the tracheal tube being inserted using the Cormack-Lehane classification system and the percentage of glottic opening (POGO).
Control group
Active

Outcomes
Primary outcome [1] 306035 0
Intubation time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry
Timepoint [1] 306035 0
The time during intubation for cesarean section when the intubation completed and corrected by an etCO2 trace.
Primary outcome [2] 306036 0
Glottic visualization time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry
Timepoint [2] 306036 0
the time during intubation for cesarean section when the glottis is visualized
Primary outcome [3] 306037 0
tracheal tube placement time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry
Timepoint [3] 306037 0
the time during intubation for cesarean section when the attending anesthesiologist achieved to place the tracheal tube to trachea
Secondary outcome [1] 347393 0
The Cormack-Lehane classification system for glottic view assessed by an anesthesiologist
Timepoint [1] 347393 0
time during intubation for cesarean section when the glottis visualized
Secondary outcome [2] 347394 0
Percentage of glottic opening assessed by the anesthesiologist. . A POGO of 100% denotes full larynx visualization from the interarytenoid notch to the anterior commissure of the vocal cords. A POGO score of zero means none of the glottic opening is seen.
Timepoint [2] 347394 0
the time during intubation for cesarean section when the glottis visualized
Secondary outcome [3] 347395 0
Change in mean arterial pressure by using blood pressure monitor on the anesthesia workstation
Timepoint [3] 347395 0
assessed continuously throughout cesarean section
Secondary outcome [4] 347396 0
Change in heart rate by using electrocardiogram on the anesthesia workstation
Timepoint [4] 347396 0
assessed continuously throughout cesarean section

Eligibility
Key inclusion criteria
Patients aged between 18-45 and with an ASA physical status I-II and undergoing cesarean section will be included to the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be as follows: the presence of cardiovascular, hepatic, renal, or neuromuscular diseases, restricted neck movements, retrognathia, an American Society of Anesthesiologists (ASA) score of III or IV, a Mallampati score of IV, an airway-related surgery history, and emergency surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients will be randomized using a sealed-envelope technique (based on computer-generated random numbers).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2018
Actual
4/06/2018
Date of last participant enrolment
Anticipated
16/07/2018
Actual
10/07/2018
Date of last data collection
Anticipated
16/07/2018
Actual
10/07/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 10508 0
Turkey
State/province [1] 10508 0
Mugla

Funding & Sponsors
Funding source category [1] 299590 0
Hospital
Name [1] 299590 0
Mugla Sitki Kocman University Training and Research Hospital
Country [1] 299590 0
Turkey
Primary sponsor type
Individual
Name
Melike Korkmaz Toker
Address
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country
Turkey
Secondary sponsor category [1] 298907 0
None
Name [1] 298907 0
Address [1] 298907 0
Country [1] 298907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300491 0
T.C. Istinye University Medical Research Ethical Committee
Ethics committee address [1] 300491 0
Istinye Üniversitesi Topkapi kampüsü Maltepe Mah., Edirne Çirpici Yolu, No.9 Zeytinburnu, 34001, Istanbul/Türkiye
Ethics committee country [1] 300491 0
Turkey
Date submitted for ethics approval [1] 300491 0
09/02/2018
Approval date [1] 300491 0
01/03/2018
Ethics approval number [1] 300491 0
(2017-KAEK-120) /20

Summary
Brief summary
In difficult intubation cases, the guidelines provide recommendations for advanced airway equipment availability, and neuraxial anesthesia is encouraged. Our aim is to compare the McGrath video laryngoscope (VL) and the Macintosh direct laryngoscope (DL) according to the intubation time and glottic visualization in patients undergoing cesarean sections.
Patients undergoing cesarean sections under general anesthesia will be included in this research. This study has a prospective design, and the patients will be randomized using a sealed envelope technique into 2 groups using either the Macintosh DL or the McGrath VL. During intubation, the times to obtaining a glottic view, tracheal tube placement, and confirming tracheal intubation as confirmed by CO2 waveform observation will be recorded. The mean arterial pressures and heart rates before intubation and after intubation will also be recorded. The mean tests will be compared using an independent t test if the data distribution are normal, or a nonparametric Mann-Whitney U test if the data are not distributed normally. A p value < 0.05 will be considered to be statistically significant.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2747 2747 0 0
/AnzctrAttachments/375193-ethical committee.pdf (Ethics approval)

Contacts
Principal investigator
Name 83830 0
Dr Melike Korkmaz Toker
Address 83830 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye
Country 83830 0
Turkey
Phone 83830 0
+905054747098
Fax 83830 0
Email 83830 0
[email protected]
Contact person for public queries
Name 83831 0
Melike Korkmaz Toker
Address 83831 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye
Country 83831 0
Turkey
Phone 83831 0
+905054747098
Fax 83831 0
Email 83831 0
[email protected]
Contact person for scientific queries
Name 83832 0
Basak Altiparmak
Address 83832 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye
Country 83832 0
Turkey
Phone 83832 0
+905326726533
Fax 83832 0
Email 83832 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseComparison of the McGrath video laryngoscope and macintosh direct laryngoscope in obstetric patients: A randomized controlled trial.2019https://dx.doi.org/10.12669/pjms.35.2.646
N.B. These documents automatically identified may not have been verified by the study sponsor.