Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries

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

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

Study Overview

• Status: Completed
• Conditions: Atelectasis; Hypoxemia During Surgery
• Intervention / Treatment: Device: high flow nasal cannula; Device: nasoprong oxyen 2Litres per minute

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
      • Universiti Kebansaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient receiving high flow nasal cannula (A); 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%.	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
Active Comparator: patient receiving nasoprong oxygen 2 L/min; 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%.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident of intraoperative desaturation	desaturation is taken as any spO2 <94%	From induction time until end of surgery
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Syarifah noor nazihah binti sayed masri, MD, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: elderly; regional anaesthesia; high flow nasal cannula; orthopaedic; hypoxaemia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Pulmonary Atelectasis; Hypoxia
• Other Study ID Numbers: FFP-2020-245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No