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

Atelectasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054022
• Other study ID #: FFP-2020-245
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atelectasis
• Hypoxemia During Surgery
• Hypoxia
• Pulmonary Atelectasis

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