A study between two methods of giving oxygen to patients before putting them to sleep for surgery.The first method gives oxygen via a bag and a mask kept over the face and nose whereas the other method uses a tube to give high amounts of oxygen through the nose .

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/03/008037
• Date of registration: 08-03-2017
• Prospective Registration: Yes
• Primary sponsor: Jubilee Mission Medical College and Research Institute
• Public title: A study between two methods of giving oxygen to patients before putting them to sleep for surgery.The first method gives oxygen via a bag and a mask kept over the face and nose whereas the other method uses a tube to give high amounts of oxygen through the nose .
• Scientific title: High flow nasal oxygen versus Standard Bag Mask for Pre Oxygenation in Rapid Sequence Induction. - High RISE
• Date of first enrolment: 21-03-2017
• Target sample size: 250
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17769
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: John Paul
• Affiliation: Jubilee Misssion Medical College and Research Institute

• Name: John Paul
• Affiliation: Jubilee Misssion Medical College and Research Institute

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients requiring Rapid sequence Induction

in Operation Theatre
Exclusion criteria: (1) Contraindications for Bag Mask or HFNO,

(2) Pregnancy

(3)Patients who fail to maintain a saturation of 95 % after Pre-Oxygenation

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients Requiring Rapid sequence Induction for Anaesthesia

Intervention(s)

Intervention1: High Flow nasal Oxygen: Use of high Flow nasal oxygen for Pre oxygenation in Rapid sequence Induction
Control Intervention1: Bag Mask: Use of Bag Mask for
Pre oxygenation in Rapid Sequence Induction

Primary Outcome(s)

Mean lowest arterial oxygen saturation during Intubation.

Timepoint: primary outcome assessed by 01/03/2018

Secondary Outcome(s)

1) Percentage of patients with SpO2 less than 92 % during Intubation,

2) Time till Intubation / Rescue attempts for Intubation.

3) Number of patients for which rescue attempts for intubation were doneTimepoint: secondary outcome assessed by 01/09/2018

Secondary ID(s)

NIL

Source(s) of Monetary Support

Department of Anaesthesiology & Critical care Jubilee Mission medical College & Research institute Thrissur Kerala

Ethics review

Status: Approved
Approval date: 01/03/2017
Contact:

ECR 835 KL INST 2016