A COMPARATIVE STUDY OF PREOXYGENATION WITH PRESSURE SUPORT VENTILATION , PRESSURESUPPORT VENTILATION WITH THE POSITIVE END-EXPIRATORY PRESSURE, AND SPONTANEOUS BREATHINGWITH FACE MASK DURING GENERAL ANAESTHESIA
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- 1. In all three groups time taken for desaturation till 92% of SpO2 (IN SECONDS)
Study Overview
Brief Summary
- Among the pool of eligible candidates, after taking written informed consent
from study participants ,105 subjects will be selected randomly and will be
allotted into 3 groups, group I, group II and group III.( A simple randomisation
technique will be followed. A total of 105 random numbers will generated at the
beginning of the study and kept centrally with the study guide. While participants
will be kept blind to the procedure and group allocation, the same is not feasible
for the investigators due to the inherent nature of the interventions. Although the
statistician who performs the data analysis will be blind to the intervention, the
master chart and statistical review were also conducted by the study guide, who
will not blind to the intervention. )
- Once the subject is allocated to either of the three group, the subject will
continue to participate in the study.In the operating room, patients will be
positioned supine with their neck flexed and head extended. The American
Society of Anaesthesiologists (ASA) standard monitoring will be applied , and
pulse-oximetry of the same make will be used in all patients. Group allocation
will be disclosed to the intraoperative anesthesia team at this point.
- GA induction will be standardised. Fresh gas flow will be set at 10L/
min.Patient will be pre oxygenated for 3 minutes from this point by any of the
following methods in which they are allocated.
- Group I - The group with Facemask (with fresh gas flow of 10L/min and FiO2
100), patients will be breathing spontaneously with tidal volume breathing,
without bagging or pressure support .
- Group II - In the PSV group, the PSV will be given using BPL E-FLO 6C
Anesthesia Machine and circle absorbent system with face mask. Pressure
support of 10CmH2O and FIO2 100.6. Group III- In the PSV +PEEP group settings of PSV 10CMH2O, PEEP of 8
CmH2O, FIO2 100.
- After three minutes of pre oxygenation patient will be induced with propofol
(1.5-2.5 mg/Kg) bolus dose followed by propofol infusion of 200mcg/kg/min).
- Two check ventilation breath will be performed to ensure that the patient is
able to be ventilated - Vecuronium 0.1 mg/Kg will be administered and facemark
will be removed from patient.
- From this point ,time taken for desaturation till 92% of SpO2 (IN SECONDS)
will be recorded . Heamodynamic parameters (HR, NIBP) will be recorded. After
SpO2 reaches 92% , patients will be mask ventilated for 2 minutes, followed by
endotracheal intubation or supraglottic airway insertion will be performed and
anesthesia will be continued as per plan. .
- The correct placement of the ET tube will be confirmed by capnography and
five-point auscultation (five breaths). After this, standard management will be
followed for both ventilation and peri-operative management as per protocol for
all three groups.
11.Heamodynamic parameters will be recorded at the beginning of
preoxygeantion, at the end of pre oxygenation, at the end of safe apnea period
and 2 minutes after ventilation later.
12.The statistical analysis will be done by appropriate statistical methods like
mean,percentages, standard deviation, Chi-square test and other relevant type of
statistical tests depending upon the type of data collected.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients belonging to age group 18to 65 years undergoing elective operative procedure under general anesthesia.
- •ASA grade 1 and grade 2
- •Patients Room air peripheral oxygen saturation of more than 97%
- •Body mass index (BMI) of 18 to 26.0 kg per metre square.
Exclusion Criteria
- •1.Patients with history of respiratory disease 2.Patients having lesions / tumours of tracheobronchial tree and upper airway.
- •3.Patients with history of cardiac disorder affecting the effort tolerance 4.Patients with history of neurological disorder and neuromuscular disorders 5.Patients with anticipated difficult intubation.
- •6.Patients posted for emergency surgeries 7.Pregnant patients and patients with risk of aspiration.
Outcomes
Primary Outcomes
1. In all three groups time taken for desaturation till 92% of SpO2 (IN SECONDS)
Time Frame: AT BASELINE
will be recorded .
Time Frame: AT BASELINE
2. Heamodynamic parameters (HR, NIBP) will be recorded
Time Frame: AT BASELINE
Secondary Outcomes
- Heamodynamic parameters (HR, NIBP) will be recorded(MEASUREMENT ET EVERY MIUTE TILL SPO2 REACHES 92% AND AFTER 2 MINUTES OF VENTILATION LATER)