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

Not Applicable

Completed

• Conditions: Hypoxemia During Surgery; Atelectasis
• Interventions: Device: high flow nasal cannula; Device: nasoprong oxyen 2Litres per minute

• Registration Number: NCT06054022
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2020-11-10
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-31
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient receiving high flow nasal cannula (A)	high flow nasal cannula	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 receiving nasoprong oxygen 2 L/min	nasoprong oxyen 2Litres per minute	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%.

Primary Outcome Measures

Name	Time	Method
Incident of intraoperative desaturation	From induction time until end of surgery	desaturation is taken as any spO2 \<94%
Patient comfort on high flow nasal cannula	At end of surgery till discharge to ward (recovery area)	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	From end of operation until 24 hours post surgery	Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Time of hospital admission to time of discharge up to 30 days which ever come first	Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital

Trial Locations

Locations (1)

Universiti Kebansaan Malaysia; 🇲🇾 Cheras, Wilayah Persekutuan Kuala Lumpur, Malaysia