Skip to main content
Clinical Trials/CTRI/2024/03/064561
CTRI/2024/03/064561Not yet recruitingNot Applicable

Comparison of safe apnea time with and without Positive End-Expiratory Pressure during face mask ventilation in adult patients undergoing general anesthesia.

Vardhaman Mahavir Medical College and Safdarjung Hospital1 site in 1 country60 target enrollmentStarted: April 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare the safe apnea time

Study Overview

Brief Summary

Face Mask Ventilation is done immediately after the induction of general anesthesia, there are various techniques to do face mask ventilation and one of which is administration of positive end expiratory pressure during face mask ventilation. Here we are trying to compare the duration of safe apnea time after administration of positive end expiratory pressure and without it and determine which has more duration. This can help the anesthesiologists to follow a standard technique to counter any unanticipated cannot ventilate cannot intubate situation if at all it happens. The methodology will be, after explaining the subjects who are posted for elective surgery about the study and getting informed consent. The subjects are divided into 2 groups (group P - PEEP of 6cmH2O and group C - PEEP of 0cmH2O) using block randomization and allotted into 1 of the 2 groups. The patient will be taken to operation theatre and general anesthesia will be induced after which face mask ventilation will be done using the ventilator and according to their groups. After 3 minutes of face mask ventilation the timer will started to document the apnea time i.e., the duration taken for SpO2 to drop from 100% to 95%. We hypothesize that the duration of apnea will be longer in group P when compared to group C. We are also trying to see the difference in PaO2/FiO2 ratio between the 2 groups

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients of age between 18-60 years belonging to ASA grade I-II undergoing elective surgery under general anesthesia with Endotracheal Intubation (ETT).

Exclusion Criteria

  • SpO2 less than 97% at room air
  • Body Mass Index more than 25kg/m2
  • Anticipated difficult intubation/ventilation
  • Indwelling nasogastric tube
  • History of Obstructive sleep apnoea
  • History of any Respiratory illness 7.

Outcomes

Primary Outcomes

To compare the safe apnea time

Time Frame: the safe apnoea time will be the duration from the moment the face mask ventilation is stopped to the moment the spo2 drops till 95%

Secondary Outcomes

  • To compare PaO2/FiO2 ratio(ABG will be taken immediately after the 3 minutes of face mask ventilation)

Investigators

Sponsor
Vardhaman Mahavir Medical College and Safdarjung Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Deepak Raj G

VMMC and Safdarjung Hospital

Study Sites (1)

Loading locations...

Similar Trials