Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202665252087 Date of Approval: 10/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nasopharyngeal Apnoeic Oxygenation at 18l/min in Obese Patients: A Randomised Controlled Study
Official scientific title Nasopharyngeal Apnoeic Oxygenation at 18l/min in Obese Patients: A Randomised Controlled Study
Brief summary describing the background and objectives of the trial The obese patient commonly poses anatomical and physiological challenges during airway management. Apnoeic oxygenation techniques, most recently THRIVE, have proven beneficial in increasing safe apnoea time (SAT). THRIVE’s cost is a significant limitation in a low-to-middle income context (LMIC). This study investigated a nasopharyngeal apnoeic oxygenation technique (NICA-O2), as a low-cost alternative. An open-label, blinded, randomised controlled, efficacy study was conducted on a cohort of obese patients (BMI>35kg/m2) undergoing elective surgery. Patients were allocated by sealed envelope method and block randomization in a 1:2 ratio. Study arms were NoAO (no apnoeic oxygenation) and AO (nasopharyngeal apnoeic oxygenation at 18l/min). All patients received a standardized induction protocol, including preoxygenation to ETO2>80%. At loss of consciousness, a nasopharyngeal airway was inserted, and the allocated study arm commenced. The desaturation process was recorded until endpoints (SpO2 of 92% and SAT of 600s) were met. Primary outcome (SAT) was time from apnoea to SpO2 of 92%. Secondary outcomes were CO2 accumulation and desaturation determinants. Survival analysis was used for SAT and descriptive and inferential statistics for secondary outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2021
Actual trial start date 01/10/2021
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No Apnoeic Oxygenation No oxygen given during the intervention Desaturation until 92 % or 600s A nasopharyngeal airway will be inserted into the nose and the oxygen tubing connected. There will be no oxygen flowing to the patient i.e 0l/min. The flow gage will be hidden from the primary investigator. Airway patency will be maintained with a jaw thrust. 10 Uncontrolled
Experimental Group Apnoeic Oxygenation at 18lmin Oxygen given at 18l/min during the apnoea period Desaturation until 92 % or 600s A nasopharyngeal airway will be inserted into the nose and the oxygen tubing connected. The oxygen flow rate will be set at 18l/min at 100%. The flow gage will be hidden from the primary investigator. Airway patency will be maintained with a jaw thrust. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Elective surgery requiring intubation with muscle relaxation • Patients older than 18 years • Obese patients with a BMI > 35 kg/m2 • ASA 1 and 2 patients • Patient < 18 years old • ASA ≥ 3 • Pregnant patients • Severe gastro-oesophageal reflux disease or aspiration risk • Severe obstructive sleep apnoea • Limiting chronic respiratory and cardiovascular disease (NYHA ≥ 3) • Uncontrolled hypertension, ischaemic heart disease, congestive heart disease • Anaemia (Hb<10) or Polycythaemia (Hb>17) • Sepsis or other uncontrollable cause of increased metabolic demand • Raised intracranial pressure • Arterial saturation < 98% at maximum preoxygenation • Difficult clinical airway assessment (patient will likely be difficult to intubate) • Increased risk of bleeding • Bleeding at the insertion of the nasopharyngeal catheter • Grade 3 or 4 Cormack-Lehane view at intubation • Difficult bagging at the induction of anaesthesia • Allergy to any of the drugs used in the study • The patient declined to be part of the study or unable to provide informed consent Symptoms of COVID 19 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/09/2020 Health Research Ethics Committee 2 Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
University of Stellenbosch, Faculties of Health Sciences, 5th Floor, Education Building Francie van Zijl-rylaan Parow 7500 Cape Town South Africa Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safe apnoea time time from apnoea until an arterial saturation of 92 percent arterial saturation at 92 percent or 600s
Secondary Outcome Rate of carbon dioxide accumalation Increase in CO2 during the study duration
Secondary Outcome Desaturation determinants During analysis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie Van Zijl Drive Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 3 Gumtree Lane Cape TOwn 7806 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthethics and Critical Care Tygerberg Hospital, Francie van zyl Drive Cape Town 7505 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Jonathon Burke Tygrberg Hospital, Francie van zyle drive Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Scott Pierpoint scott.pierpoint@gmail.com 0839478893 3 Gumtree Lane, Hout Bay
City Postal code Country Position/Affiliation
Cape Town South Africa Registrar
Role Name Email Phone Street address
Public Enquiries Scott Pierpoint scott.pierpoint@gmail.com 0839478893 3 Gumtree Lane, Hout Bay
City Postal code Country Position/Affiliation
Cape Town South Africa Registrar
Role Name Email Phone Street address
Scientific Enquiries Scott Pierpoint scott.pierpoint@gmail.com 0839478893 3 Gumtree Lane
City Postal code Country Position/Affiliation
Cape Town South Africa Registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Section A - Individual Data Sharing Statement Individual participant data be available (including data dictionaries). No identifying data of the indivuals will be available (complete de-identification) Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report and Analytic Code will be made available Data will be made availablee immediately following publication (subject to Journal terms) Data will be available to researches with a sound methodological proposal who wishes to access the data Data available for analysis to achieve aims in the approved proposal and meta-analyses Data are available indefinitely at (Link to be included) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months post completion of analysis Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
pending No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information