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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06054022
Other study ID # FFP-2020-245
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2020
Est. completion date December 31, 2021

Study information

Verified date September 2023
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status


Description:

To observe the effect of high flow nasal cannula used intraoperatively compared to normal oxygen therapy (nasoprong) at a same fraction of inspired oxygen (FiO2) in elderly patients who are going for orthopaedic surgeries under central neuraxial block. oxygenation will be access with intermittent blood gas. atelectasis will be access via chest x-ray , compared to a baseline chest x-ray, validated by a blinded radiologist


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) I, II or III patients. 2. Patients age 60 years and above 3. Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list. Exclusion Criteria: 1. Patients with pre-operative spO2<94% 2. Patients delirious or demented / unable to give consent. 3. Patients with pre-existing pneumonia (defined as the initiation of antibiotics for suspected infection with one or more of the following: new or changed sputum; new or changed lung opacities; fever; white blood cell count >12 × 109 litre-1 )15 4. BMI =35

Study Design


Intervention

Device:
high flow nasal cannula
high flow nasal cannula provides heated and humidified gas to the airways via nasal prongs at a prescribed accurate fraction of inspired oxygen (FiO2) ranging from 0.21 to 1.0 and with a higher flow rate of up to 60 litres per minute
nasoprong oxyen 2Litres per minute
nasoprong @L/min will deliver approximately a FiO2 of 0.3. subsequently, if incremental O2 is needed, patient will be provided with ventimask 40% and so forth

Locations

Country Name City State
Malaysia Universiti Kebansaan Malaysia Cheras Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incident of intraoperative desaturation desaturation is taken as any spO2 <94% From induction time until end of surgery
Primary Patient comfort on high flow nasal cannula Patient rate comfort level using Visual Numerical Scale. The scale of 1 to 5 with 1 being extreme discomfort, 3 neutral and 5 extreme comfort At end of surgery till discharge to ward (recovery area)
Primary Atelactasis Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist From end of operation until 24 hours post surgery
Secondary Length of hospital stay Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital Time of hospital admission to time of discharge up to 30 days which ever come first
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