Back to resultsUsage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries
Primary Purpose
Hypoxemia During Surgery, Atelectasis
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
high flow nasal cannula
nasoprong oxyen 2Litres per minute
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxemia During Surgery focused on measuring high flow nasal cannula, elderly, orthopaedic, hypoxaemia, regional anaesthesia
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) I, II or III patients. Patients age 60 years and above Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list. Exclusion Criteria: Patients with pre-operative spO2<94% Patients delirious or demented / unable to give consent. 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 BMI ≥35
Sites / Locations
- Universiti Kebansaan Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient receiving high flow nasal cannula (A)
patient receiving nasoprong oxygen 2 L/min
Arm Description
Patient will be put on high flow nasal cannula at a fixed flow of 50L/min, at Fio2 0.3% throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.
Patient will be put nasoprong oxygen 2L/min throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.
Outcomes
Primary Outcome Measures
Incident of intraoperative desaturation
desaturation is taken as any spO2 <94%
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
Atelactasis
Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist
Secondary Outcome Measures
Length of hospital stay
Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital
Full Information
NCT ID
NCT06054022
First Posted
November 10, 2020
Last Updated
September 21, 2023
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT06054022
Brief Title
Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries
Official Title
Comparing Intraoperative High Flow Nasal Cannula Therapy and Convetional Oxygen Therapy in Preventing Perioperative Hypoxaemia In Elderly Patients Undergoing Orthopaedic Surgery: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia During Surgery, Atelectasis
Keywords
high flow nasal cannula, elderly, orthopaedic, hypoxaemia, regional anaesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
there will be no masking except for the radiologist who compares the postoperative chest x-ray with the baseline
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient receiving high flow nasal cannula (A)
Arm Type
Experimental
Arm Description
Patient will be put on high flow nasal cannula at a fixed flow of 50L/min, at Fio2 0.3% throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.
Arm Title
patient receiving nasoprong oxygen 2 L/min
Arm Type
Active Comparator
Arm Description
Patient will be put nasoprong oxygen 2L/min throughout surgery. Oxygen therapy will be discontinued once surgery ends. FiO2 will be titrated by 0.1 increment to a SpO2 of ≥94%.
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
nasoprong oxyen 2Litres per minute
Intervention Description
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
Primary Outcome Measure Information:
Title
Incident of intraoperative desaturation
Description
desaturation is taken as any spO2 <94%
Time Frame
From induction time until end of surgery
Title
Patient comfort on high flow nasal cannula
Description
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
Time Frame
At end of surgery till discharge to ward (recovery area)
Title
Atelactasis
Description
Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist
Time Frame
From end of operation until 24 hours post surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital
Time Frame
Time of hospital admission to time of discharge up to 30 days which ever come first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) I, II or III patients.
Patients age 60 years and above
Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list.
Exclusion Criteria:
Patients with pre-operative spO2<94%
Patients delirious or demented / unable to give consent.
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
BMI ≥35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syarifah noor nazihah binti sayed masri, MD
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebansaan Malaysia
City
Cheras
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries
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