Hypoxemia During SurgeryNCT06054022
Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries
A study testing high flow nasal cannula and nasoprong oxyen 2Litres per minute in people with Hypoxemia During Surgery and Atelectasis, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypoxemia During Surgery, Atelectasis
- What is being tested?
- high flow nasal cannula and nasoprong oxyen 2Litres per minute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status
Read the 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
- Conditions
- Hypoxemia During Surgery, Atelectasis
- Being tested
- high flow nasal cannula, nasoprong oxyen 2Litres per minute
- Keywords
- high flow nasal cannula, elderly, orthopaedic, hypoxaemia, regional anaesthesia
- Medical subject headings
- Pulmonary Atelectasis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
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 minuteDevice
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
| Study group | Role | What they receive |
|---|---|---|
| patient receiving high flow nasal cannula (A) | Experimental | 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%. Receives: Device: high flow nasal cannula |
| patient receiving nasoprong oxygen 2 L/min | Active comparator | 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%. Receives: Device: nasoprong oxyen 2Litres per minute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of intraoperative desaturation
desaturation is taken as any spO2 <94%
Measured: 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
Measured: 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
Measured: From end of operation until 24 hours post surgery
Secondary outcomes (1)
Length of hospital stay
Duration of hospital admission from the time of patient admitted to the hospital, until discharge from hospital
Measured: Time of hospital admission to time of discharge up to 30 days which ever come first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start7 Jul 2020
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syarifah noor nazihah binti sayed masri, MD, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054022
- Sponsor's protocol ID
- FFP-2020-245
- Status last verified
- Sep 2023
- First submitted
- 10 Nov 2020
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06054022
- Acronym / sponsor ID
- FFP-2020-245
- Conditions
- Hypoxemia During Surgery, Atelectasis
- Keywords
- high flow nasal cannula, elderly, orthopaedic, hypoxaemia, regional anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient receiving high flow nasal cannula (A) | Experimental | Device: high flow nasal cannulaPatient 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 | Active comparator | Device: nasoprong oxyen 2Litres per minutePatient 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%. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal cannulahigh 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 | Device | patient receiving high flow nasal cannula (A) |
| nasoprong oxyen 2Litres per minutenasoprong @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 | Device | patient receiving nasoprong oxygen 2 L/min |
Primary outcome
Incident of intraoperative desaturation
Time frame: From induction time until end of surgery
desaturation is taken as any spO2 <94%
Patient comfort on high flow nasal cannula
Time frame: 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
Time frame: 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
1 secondary outcome
Length of hospital stay
Time frame: Time of hospital admission to time of discharge up to 30 days which ever come first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Hypoxemia During Surgery
Not yet recruiting
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
Hypoxemia During Surgery
Recruiting
High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery
Hypoxemia During Surgery
Enrolling by invitationObservational study
Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV?
Lung Cancer, OLV
Enrolling by invitationPhase 4
Usefulness of High-flow Oxygen Therapy of Patients at Risk of Hypoxemia Undergoing Digestive Endoscopy Under Deep Sedation
Hypoxemia During Surgery
Not yet recruitingObservational study
Association of Different Tidal Volumes and Postoperative Pulmonary Complications
Pulmonary Complications, Hypoxemia During Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syarifah noor nazihah binti sayed masri, MD principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula and nasoprong oxyen 2Litres per minute in people with Hypoxemia During Surgery and Atelectasis, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of intraoperative desaturation (time frame: From induction time until end of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.