CTRI Number |
CTRI/2016/04/006811 [Registered on: 08/04/2016] Trial Registered Retrospectively |
Last Modified On: |
06/04/2016 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
I-gel supra-glottic airway device use in laparoscopic surgery |
Scientific Title of Study
|
To determine the feasibility and safety of using I-gel supra-glottic airway device for low-flow anesthesia for laparoscopic surgery |
Trial Acronym |
igel |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Asma Murtaza Khan |
Designation |
Senior Resident Anaesthesiology |
Affiliation |
Saket City Hospital |
Address |
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 South DELHI 110017 India |
Phone |
|
Fax |
|
Email |
dr.asmakhan.sgrh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mukul Chandra Kapoor |
Designation |
Director Anesthesia |
Affiliation |
Saket City Hospital |
Address |
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 South DELHI 110017 India |
Phone |
|
Fax |
|
Email |
mukulanjali@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mukul Chandra Kapoor |
Designation |
Director Anesthesia |
Affiliation |
Saket City Hospital |
Address |
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 Saket City Hospital, Press Enclave Road, Saket, Delhi 110017
DELHI 110017 India |
Phone |
|
Fax |
|
Email |
mukulanjali@gmail.com |
|
Source of Monetary or Material Support
|
Saket City Hospital, Press Enclave Road, Saket, Delhi 110017 |
|
Primary Sponsor
|
Name |
Saket City Hospital |
Address |
Press Enclave Road, Saket, Delhi 110017 |
Type of Sponsor |
Private hospital/clinic |
|
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 Asma Murtaza Khan |
Saket City Hospital |
Department of Anesthesia, Saket City Hospital, 1st Floor, Press Enclave Road, Saket Delhi 110017 South DELHI |
9310891881
dr.asmakhan.sgrh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Saket City Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Cases for laparoscopic surgeries up to 2 hours duration, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Endotracheal tube tracheal intubation |
Airway will be secured by an appropriate size oral endotracheal tube following administration of a neuromuscular blocker |
Intervention |
Igel supraglottic airway |
Airway will be secured by an appropriate size I-gel following administration of a non-depolarizing muscle relaxant. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Age >18years
2.Elective Laparoscopic abdominal surgery with up to 2 hours duration anesthesia delivery.
3.ASA 1-3
|
|
ExclusionCriteria |
Details |
1. Patients undergoing a concomitant procedure.
2. Pulmonary disease and ASA 4.
3. Hypersensitivity to one or more medications.
4. Previous thoracic surgeries.
5. Anticipated difficult airway.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
: To determine the lowest fresh gas flow delivery at which there is no clinical leak as compared to an endotracheal tube, which is considered as the gold standard |
The parameters will be monitored and recorded every minute along with reduction of flows till 400 ml/min and thereafter every 15 min till 2 hours after which the study will be terminated. |
|
Secondary Outcome
|
Outcome |
TimePoints |
•To determine safety of use of low flow technique in terms of oxygen saturation.
•To evaluate the ease of placing the oro/naso gastric tube
•To determine the incidence of adverse effects of the two devices
|
The parameters will be monitored and recorded every minute along with reduction of flows till 400 ml/min and thereafter every 15 min till 2 hours after which the study will be terminated. |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
06/07/2015 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
All patients
would undergo a pre-anesthetic evaluation comprising of history, general
physical and systemic examinations. All efforts will be focused on the
identification of any comorbid diseases and their optimization before surgery.
Preoperative investigations would be appropriately performed to guide and
optimize perioperative management. All patients shall be kept fasting for at
least 6 hours.
Patients will be allocated to two groups of 25
patients each by random computer draw.
Group A - Securing airway with I-gel supraglottic
airway device.
Group B - Securing airway with endotracheal tube
(ETT).
All patients will be administered general anesthesia
for the procedure. A Drager Fabius Plus Anesthesia Machine will be used in all
cases with a co-axial closed circuit breathing system. A standardized protocol
for induction and maintenance of anesthesia will be followed which would
comprise of intravenous fentanyl (1-2mcg/kg) followed by propofol (1.5-2mg/kg)
for induction. Airway will be secured by an appropriate size oral ETT or I-gel
following administration of a non-depolarizing muscle relaxant. The head end of
the patient will be covered with drapes to facilitate blinding of the
investigator. Anesthesia will be maintained with desflurane in oxygen and
nitrous oxide titrated to maintain FiO2 of 0.5 at all times. A non-depolarizing
muscle relaxant will be administered for maintenance of neuromuscular blockade
during the surgical procedure. Standard volume control ventilation settings
will be used in both groups with tidal volume of 8ml/kg, to maintain minute
ventilation of 100ml/kg and end-tidal carbon dioxide (EtCO2) between
30-40 mm Hg.
Initially high fresh gas flows (FGF) of 6 l/min will
be used to achieve desired expired concentration of anesthetic gases and then FGF
reduced to 1000 ml/min. The time of initiation of a FGF of 1000ml/min will be
considered as Time 0. FGF will then be reduced by 100 ml/min till the final
goal of 400 ml/min total FGF is achieved, which will be recorded as a state of
no clinical leak in the breathing system. The FGF will not be reduced below the
above limit. The FGF will not be reduced in case of collapse of bellows,
ventilation alarms or desaturation. An independent observer, unaware of the
airway device used, will record all observations. The parameters will be
monitored and recorded every minute along with reduction of flows till 400 ml/min
and thereafter every 15 min till 2 hours after which the study will be
terminated. The following parameters will be recorded:
- Heart rate
- Blood pressure
- Oxygen saturation
- End tidal Carbon dioxide
- Peak Airway pressure
- Loss of tidal volume (Set tidal volume - Delivered
tidal volume)
- Total Flow delivered
- Changes in above parameters with change in position from
supine to Trendelenberg or reverse Trendelenberg.
Efficiency
of placing naso/oro-gastric tube will be noted along with gastric distension at
the beginning and end of surgery. At the end of the procedure, neuromuscular
blockade will be reversed and post extubation patient will be shifted to PACU
for observation.
Patients will be followed up in PACU and 24 hours
after surgery in wards to note complaints of sore throat (constant pain, independent
of swallowing, dysphagia, pain with swallowing), sore jaw, dysphonia, numbness
of tongue or oropharynx, blocked or painful ears, reduced hearing or neck pain.
Statistical Power: The
power of the study was calculated based on the study by Uppal et al1
comparing I-gel with ETT using pressure controlled ventilation. To
estimate the sample size a mean difference of 0.25 was considered to get
clinically significant results between the two groups. The standard deviation
value used was 0.05. Using a power of 80% and a significance value of 0.05 for
a two-sample t-test comparing two groups a total of 24 patients per group would
be needed.
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