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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]

none

Universal Trial Number (UTN)

none

Trial acronym

none

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pregnancy

cesarean section

childbirth

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Reproductive Health and Childbirth

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]

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]

Intubation time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry

Timepoint [1]

The time during intubation for cesarean section when the intubation completed and corrected by an etCO2 trace.

Primary outcome [2]

Glottic visualization time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry

Timepoint [2]

the time during intubation for cesarean section when the glottis is visualized

Primary outcome [3]

tracheal tube placement time administered by either McGrath video laryngoscope or Macintosh direct laryngoscope assesed by using a chronometry

Timepoint [3]

the time during intubation for cesarean section when the attending anesthesiologist achieved to place the tracheal tube to trachea

Secondary outcome [1]

The Cormack-Lehane classification system for glottic view assessed by an anesthesiologist

Timepoint [1]

time during intubation for cesarean section when the glottis visualized

Secondary outcome [2]

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]

the time during intubation for cesarean section when the glottis visualized

Secondary outcome [3]

Change in mean arterial pressure by using blood pressure monitor on the anesthesia workstation

Timepoint [3]

assessed continuously throughout cesarean section

Secondary outcome [4]

Change in heart rate by using electrocardiogram on the anesthesia workstation

Timepoint [4]

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?

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]

Turkey

State/province [1]

Mugla

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mugla Sitki Kocman University Training and Research Hospital

Address [1]

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

T.C. Istinye University Medical Research Ethical Committee

Ethics committee address [1]

Istinye Üniversitesi Topkapi kampüsü Maltepe Mah., Edirne Çirpici Yolu, No.9 Zeytinburnu, 34001, Istanbul/Türkiye

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

09/02/2018

Approval date [1]

01/03/2018

Ethics approval number [1]

(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]

/AnzctrAttachments/375193-ethical committee.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Melike Korkmaz Toker

Address

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye

Country

Turkey

Phone

+905054747098

Fax

[email protected]

Contact person for public queries

Name

Melike Korkmaz Toker

Address

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye

Country

Turkey

Phone

+905054747098

Fax

[email protected]

Contact person for scientific queries

Name

Basak Altiparmak

Address

Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon A.D, Mugla, 48001, Türkiye

Country

Turkey

Phone

+905326726533

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Comparison of the McGrath video laryngoscope and macintosh direct laryngoscope in obstetric patients: A randomized controlled trial.	2019	https://dx.doi.org/10.12669/pjms.35.2.646

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically