| CTRI Number |
CTRI/2017/07/009142 [Registered on: 27/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluation of head positions for laryngoscopy and intubation. |
|
Scientific Title of Study
|
Comparative evaluation of laryngoscopy position in adults attained by conventional 7cm head raise and that attained by horizontal alignment of external auditory meatus-sternal notch line |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anant Vikram Pachisia |
| Designation |
Resident Doctor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Anaesthesia,3rd floor, B L Taneja building. Lok Nayak Hospital/ Maulana Azad Medical College, New Delhi
West DELHI 110002 India |
| Phone |
9810368132 |
| Fax |
|
| Email |
anantndin@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kavita Rani Sharma |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Anaesthesia,3rd floor, B L Taneja building. Lok Nayak Hospital/ Maulana Azad Medical College, New Delhi
West DELHI 110002 India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anant Vikram Pachisia |
| Designation |
Resident Doctor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department Of Anaesthesia,3rd floor, B L Taneja building. Lok Nayak Hospital/ Maulana Azad Medical College, New Delhi
West DELHI 110002 India |
| Phone |
9810368132 |
| Fax |
|
| Email |
anantndin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadur Shah Zafar Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Department fo Anaesthesia, 3rd floor, B L Taneja block, Bahadur shah zafar marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anant Vikram Pachisia |
Lok Nayak Hospital |
Lok Nayak Hospital,Jawahar lal Nehru Marg, New Delhi -110002 Central DELHI |
9810368132
anantndin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA GRADE I-III, 18 -65 YEARS OF AGE. PLANNED FOR ELECTIVE SURGERY, MODIFIED MALLAMPATI CLASS I-III, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-H |
Horizontal alignment of external auditory meatus -sternal notch line was used for attaining first laryngoscopy position, follow by using 7cm uncompressible pillow for second laryngoscopy position and intubation. |
| Intervention |
Group-S |
7cm uncompressible pillow below head of the patient was used for attaining first laryngoscopy position, followed by horizontal alignment of external auditory meatus -sternal notch line for attaining second laryngoscopy position and intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) American society of anaesthesia grade I-III
2) Planned for elective surgery under general anaesthesia.
3) Modified mallampati class I-III |
|
| ExclusionCriteria |
| Details |
1) Inadequate cervical spine mobility/ cervical malformation/ unstable cervical spine
2) Requiring rapid sequence induction
3) Planned for awake intubation
4) Planned for nasal intubation
5) Mouth opening less than 3cm
6) Recent upper respiratory tract infection
7) Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Laryngoscopy view grading |
Modified cormack lehane grading |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Head rise to achieve horizontal line between external auditory meatus and sternal notch |
Centimeters |
| Time to intubate |
Seconds |
| Intubation difficulty score |
Intubation difficulty score |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2013 |
| Date of Study Completion (India) |
31/12/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
sniffing position (SP) has been traditionally been considered the optimal head
position for direct laryngoscopy (DL). In
this position, the neck must be flexed on the chest, typically by elevating the
head with a cushion under the occiput and extending the head on the
atlanto-occipital joint. However, the degree of head raise required
to achieve an optimal cervical spine flexion is not clear. It has been
suggested that a horizontal alignment of the external auditory meatus - sternal
notch line produces a better alignment of the airway axes. It was postulated
that this alignment may provide a better laryngoscopic view and ease of
intubation.
After
approval from institutional review board, this prospective, randomized,
cross-over study titled “Compare evaluation
of laryngoscopy positions in adults attained by conventional 7cm head raise
with that attained by horizontal alignment of external auditory meatus -
sternal notch line†was conducted. 100 ASA I-III for elective surgery
participated in this study. They were divided into two groups: S & H, with
50 patients each.
Patient
was premedicated with i.v. fentanyl 2 microgram/kg 5min before induction. After
preoxygenation with 100% O2 for 3min, anaesthesia was induced with
i.v. propofol 2mg/kg. Ability to mask ventilate was checked. Muscle relaxation
was achieved using i.v.vecuronium 0.1mg/kg. The patient was ventilated via
facemask with 2% isoflurane in oxygen for three minutes before attempting
laryngoscopy in either group.
In one group (Group-H), patients were
positioned such that external auditory meatus and sternal notch (AM-S line)
were in same horizontal line during first laryngoscopy. The second laryngoscopy
was performed with patient head placed on 7cm pillow. Thereafter, patient was
intubated in second position. In the other group (Group-S), laryngoscopy was
performed first with head placed on 7cm pillow while second laryngoscopy was
performed with AM-S line horizontal alignment and patient intubated in second
position. Modified Cormack Lehane
grading of laryngeal view in both the head positions were compared, along with
ease of intubation (Intubation difficulty score) and the time to intubate
between the two groups. The time to intubate was from the introduction of
laryngoscopy blade into the mouth till the appearance of square wave capnograph
trace.
Results:
All the patients who participated in the study were demographically matched for
age, weight and gender between the two groups: S and H. There was no
statistical difference in any of demographic parameters.
All
the patients had laryngoscopic view evaluated with both the positions i.e. AM-S
alignment and with a 7cm head raise. One patient had AM-S line alignment at 7cm;
hence laryngoscopy was performed only once followed by intubation.
During
CL grading with AM-S alignment, 40% patients had CL grade I, while only 30%
patients had CL grade I with 7cm head raise. In 7cm head raise position, 40%
patients had CL IIa and CL IIb was present in 21% patients. When
compared to AM-S line alignment, CL IIa was present in 36% patients while CL
IIb was present in 15% patients. For CL IIIa, results were almost similar for
AM-S group and 7cm head raise group having 9% and 8% incidence respectively.
Interestingly, CL grade IIIb was not encountered during
laryngoscopic grading in AM-S alignment but one patient (1%) had CL IIIb during
laryngoscopy with 7 cm head raise. There was statistically significant
difference between CL grades for two positions. For MMPC- I & II, CL grades
improved with AM-S alignment (p<0.05) but not for MMPC-III.
Al-Jadidi
et al used a single infusion bag with a head ring placed in it for
finding optimal sniffing position. We found that their infusion bag assembly
was unstable during intubation and also indentation would occur when patients
head was placed on it. We devised an innovative inflatable pillow made using
two pressure infusion bags connected using a three way to single inflation
bulb. This assembly was then placed between two firm surfaces (wooden base and
stiff plastic sheet on top) and then encased in a cover. This prevented the
indentation of the pillow by the patient’s head which changes the height of
head raise. This assembly allowed the head raise to be adjusted between 3cm to
10cm by progressive inflation. The degree of head raise was recorded by a scale
fixed to the base of this pillow and the height could be recorded in cm with a
least count of 1mm. The inflation bulb could be controlled easily. Using two
pressure bags side by side provided stability and allowed a uniform height of
the pillow.
The
mean IDS for group-S was less than that for group-H, being 1.18±1.69 and 2±1.59
(p<0.05) respectively. The time to intubate in AM-S line alignment position
was 17.33±4.52 sec while that with 7cm
pillow was 18.44±4.64 sec (p<0.05). Significantly lesser amount of lifting
force was required for laryngoscopy in AM-S line alignment position (p<0.05
The
mean head raise required for AM-S alignment in this study 4.920±1.460 cms.
Sinha et al in their study found that 4.5cm pillow provided best laryngeal
view, compared to 9 & 13.5cm pillow. However in contrast Park et al found
best possible laryngeal view with 9cm pillow. Schmitt and Mang suggested that elevation of the head and neck
beyond the sniffing position may improve visualization of the glottic
structures in case of difficult laryngoscopy, leading to better intubation
performance. Levitan et al in their cadaveric study also found POGO scores to
improve with increasing head elevation. Likely explanation is that our study
and that done by Sinha et al were conducted in Asian population while the
latter mention studies were conducted on population of western countries, who
have larger body proportions, thus likely to have longer neck length compared
to Asians and hence require a greater head raise.
From
the results of present study we conclude that External Auditory Meatus-Sternal
notch alignment (AM-S alignment) provides better laryngeal view as compared to
conventional sniffing position with 7cm head raise. We also conclude that AM-S
alignment provides better intubating conditions, and requires lesser time to
intubate as compared to a conventional 7cm head raise. The size of pillow used
for head raise should be individualised. The horizontal alignment of auditory
meatus - sternal notch line can be used as an end point for attaining proper
laryngoscopic position. An average pillow height of 4.920±1.460 cm conforms
more closely to a proper laryngoscopy position as compared to a 7cm pillow in
Indian patients.
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