Obesity Clinical Trial
Official title:
Effect of High-flow vs. Low-flow Nasal Oxygenation on Spontaneous Ventilation in Obese Adult Patients During Analgo-sedation for Vitrectomy, Randomized Controlled Trial
Patients suffering from pathology of posterior eye chamber such as diabetic retinopathy,
retinal detachment, traumatic eye injury, retained lens fragments, macular hole, pucker,
dislocated intraocular lens after cataract surgery or vitreomacular traction are often
subjected to pars plana vitrectomy (PPV). PPV is minimally invasive endo-microscopic
operation usually performed in topical anesthesia combined with sub-Tenon or retrobulbar
block done by surgeon, supplemented by intravenous analgo-sedation given by anesthesiologist.
Continuous infusion and dose adjustment of intravenous anesthetics applied should procure
moderate sedation and preservation of patients' spontaneous ventilation. However, despite
carefully applied anesthetics and standard low-flow nasal oxygenation (LFNO) (5 L/min O2 via
nasal catheter), inadequate spontaneous breathing can occur leading to low blood oxygen level
(hypoxia). Obese patients are susceptible to hypoxia and hypercapnia (high CO2 blood level)
during analgo-sedation. Respiratory instability of obese patients is often associated to
their subsequent circulatory instability (heart rate and blood pressure disorders).
On the other hand, high-flow nasal oxygenation (HFNO) is usually used during anesthesia
induction when difficult maintenance of airway patency is expected, in intensive care units
during weaning patients from mechanical respirator and in postanesthesia care units during
awakening from anesthesia. It can deliver 20 to 70 L/min, up to 100% inspiratory fraction of
O2 (FiO2) to patient. High oxygen/air flow produces 3-7 cmH2O of continuous pressure in
patients' upper airways therefore providing better oxygenation. Oxygen/air mixture delivered
by HFNO is humidified and heated, thus more comfortable to patient than dry and cold LFNO.
Aim of this study is to compare effect of HFNO to LFNO during intravenously applied
standardized analgo-sedation given for PPV in obese adult patients.
Investigators hypothesize that obese patients, whose breathing pattern is preserved,
receiving HFNO vs. LFNO during standardized analgo-sedation for PPV will be more respiratory
and circulatory stable, preserving normal blood O2 and CO2 level, breathing pattern, heart
rate and blood pressure.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | August 1, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Normal weight and obese patients (18<BMI<30 kg/m2, 30=BMI<35 kg/m2, BMI=35 kg/m2) - Moderate intravenous analgo-sedation - Pars plana vitrectomy Exclusion Criteria: - Higher anesthesia risk patients (ASA III) - Conventional vitrectomy - Diseases of peripheral blood vessels - Hematological diseases - Psychiatric diseases - Sideropenic anemia - Patient's refusal - Ongoing chemotherapy or irradiation - Remifentanyl and Xomolix allergies |
Country | Name | City | State |
---|---|---|---|
Croatia | University clinical hospital centre Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Split, School of Medicine | Clinical Hospital Centre Zagreb |
Croatia,
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Bricout M, Feldman, Rochepeau C, Hafidi M, Labeille E, Cornut PL. [Outpatient vitreoretinal surgery without next-day examination: Feasibility and acceptability]. J Fr Ophtalmol. 2018 Nov;41(9):852-856. doi: 10.1016/j.jfo.2018.01.025. Epub 2018 Oct 17. French. — View Citation
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Lee CC, Perez O, Farooqi FI, Akella T, Shaharyar S, Elizee M. Use of high-flow nasal cannula in obese patients receiving colonoscopy under intravenous propofol sedation: A case series. Respir Med Case Rep. 2018 Feb 3;23:118-121. doi: 10.1016/j.rmcr.2018.01.009. eCollection 2018. — View Citation
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Nagata K, Morimoto T, Fujimoto D, Otoshi T, Nakagawa A, Otsuka K, Seo R, Atsumi T, Tomii K. Efficacy of High-Flow Nasal Cannula Therapy in Acute Hypoxemic Respiratory Failure: Decreased Use of Mechanical Ventilation. Respir Care. 2015 Oct;60(10):1390-6. doi: 10.4187/respcare.04026. Epub 2015 Jun 23. — View Citation
Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13. Review. — View Citation
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Shah U, Wong J, Wong DT, Chung F. Preoxygenation and intraoperative ventilation strategies in obese patients: a comprehensive review. Curr Opin Anaesthesiol. 2016 Feb;29(1):109-18. doi: 10.1097/ACO.0000000000000267. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maintaining oxygenation above the level of hypoxemia. Measure: peripheral blood saturation (SpO2) before application of LFNO or HFNO. | Normal range >92% Acceptable deflection from normal values of peripheral blood saturation (SpO2) significant for hypoxemia is =92%, while all values above will be considered normal. SpO2 will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Time 0=before oxygenation | |
Primary | Maintaining oxygenation above the level of hypoxemia. Measure: peripheral blood saturation (SpO2) 15 minutes after institution of LFNO or HFNO. | Normal range >92% Acceptable deflection from normal values of peripheral blood saturation (SpO2) significant for hypoxemia is =92%, while all values above will be considered normal. SpO2 will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Time 1=15 minutes after institution of LFNO or HFNO, | |
Primary | Maintaining oxygenation above the level of hypoxemia. Measure: peripheral blood saturation (SpO2) 5 minutes after discontinuing analgo-sedation and oxygenation (LFNO and HFNO). | Normal range >92% Acceptable deflection from normal values of peripheral blood saturation (SpO2) significant for hypoxemia is =92%, while all values above will be considered normal. SpO2 will be observed during procedure so that we can confirm or exclude differences connected with practical application of LFNO and HFNO. | Time 2=5 minutes after discontinuing analgo-sedation and oxygenation (LFNO and HFNO). | |
Secondary | Maintaining of expiratory efficiency of spontaneous breathing below hypercapnia value. Measure: expiratory level of CO2 (expCO2) before oxygenation by LFNO or HFNO. | Normal range: 34 - 45 mmHg. Acceptable deflection from normal values significant for hypercapnia: expCO2 > 45 mmHg. | Time 0=before oxygenation by LFNO or HFNO | |
Secondary | Maintaining of expiratory efficiency of spontaneous breathing below hypercapnia value. Measure: expiratory level of CO2 (expCO2) 15 minutes after institution of LFNO or HFNO. | Normal range: 34 - 45 mmHg. Acceptable deflection from normal values significant for hypercapnia: expCO2 > 45 mmHg. | Time 1=15 minutes after institution of LFNO or HFNO | |
Secondary | Maintaining of expiratory efficiency of spontaneous breathing below hypercapnia value. Measure: expiratory level of CO2 (expCO2) 5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | Normal range: 34 - 45 mmHg. Acceptable deflection from normal values significant for hypercapnia: expCO2 > 45 mmHg. | Time 2=5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: frequency of breathing Measure: frequency of breathing before oxygenation by LFNO or HFNO. | Frequency of breathing. Normal range: 12-20 breaths per minute. Frequency of breathing (FoB) - number of breaths per minute. | Time 0=before oxygenation by LFNO or HFNO. | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: frequency of breathing Measure: frequency of breathing 15 minutes after institution of LFNO or HFNO. | Frequency of breathing. Normal range: 12-20 breaths per minute. Frequency of breathing (FoB) - number of breaths per minute. | Time 1=15 minutes after institution of LFNO or HFNO. | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: frequency of breathing. Measure: frequency of breathing 5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | Frequency of breathing. Normal range: 12-20 breaths per minute. Frequency of breathing (FoB) - number of breaths per minute. | Time 2=5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: frequency of bradypnoea during analgo-sedation and oxygenation by LFNO or HFNO (fBRP/min). | Frequency of breathing. Normal range: 12-20 breaths per minute. Bradypnoea will be noted when number of breaths is less then 12 breaths per minute. Normal range: up to one episode of bradypnoea during procedure. Acceptable deflection from normal range: >1 episode of bradypnoea during procedure. | Procedure (From the start until the end of analgo-sedation and oxygenation by LFNO or HFNO.) | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: frequency of desaturation during time of analgo-sedation and oxygenation by LFNO or HFNO. | Frequency of desaturation during time of analgo-sedation: fDE, SpO2<92%. Normal range fDE = 1/60 min. Acceptable deflection from normal range: a ratio higher than 1/60 min. | Procedure (From the start until the end of analgo-sedation and oxygenation by LFNO or HFNO.) | |
Secondary | Maintaining of normopnoea and spontaneous ventilation: Duration of desaturation (DE/min) from the start until the end of analgo-sedation and oxygenation by LFNO or HFNO. | Normal range: SpO2<92% up to one minute. Duration of desaturation longer than one minute will be considered as insufficient ventilation. | up to 1 minute (From the start until the end of analgo-sedation and oxygenation by LFNO or HFNO.) | |
Secondary | Measurement of procedural parameters: duration of analgo-sedation. | Duration of analgo-sedation (min) - expected duration (minutes). | Procedure (From the start until the end of analgo-sedation.) | |
Secondary | Measurement of procedural parameters: duration of awakening (awaken patient). | Duration of awakening (min) - expected duration up to 5 minutes (minutes). | up to 5 minutes | |
Secondary | Circulatory stability: heart rate before oxygenation by LFNO or HFNO | Heart rate (HR/min): normal range 60-100/min. Acceptable deflection from normal values is <60/heartbeats/min significant for bradycardia, while all values up to 100 heartbeats per minute will be considered normal. | Time 0=before oxygenation by LFNO or HFNO | |
Secondary | Circulatory stability: heart rate 15 minutes after institution of LFNO or HFNO. | Heart rate (HR/min): normal range 60-100/min. Acceptable deflection from normal values is <60/heartbeats/min significant for bradycardia, while all values up to 100 heartbeats per minute will be considered normal. | Time 1=15 minutes after institution of LFNO or HFNO. | |
Secondary | Circulatory stability: heart rate 5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | Heart rate (HR/min): normal range 60-100/min. Acceptable deflection from normal values is <60/heartbeats/min significant for bradycardia, while all values up to 100 heartbeats per minute will be considered normal. | Time 2=5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | |
Secondary | Circulatory stability: mean arterial pressure before oxygenation by LFNO or HFNO | Mean arterial pressure (MAP): normal range: 65 - 110/min Acceptable deflection from normal values is <65 mmHg significant for hypotension, >110 mmHg for hypertension. | Time 0=before oxygenation by LFNO or HFNO. | |
Secondary | Circulatory stability: mean arterial pressure 15 minutes after institution of LFNO or HFNO | Mean arterial pressure (MAP): normal range: 65 - 110/min Acceptable deflection from normal values is <65 mmHg significant for hypotension, >110 mmHg for hypertension. | Time 1=15 minutes after institution of LFNO or HFNO. | |
Secondary | Circulatory stability: mean arterial pressure 5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). | Mean arterial pressure (MAP): normal range: 65 - 110/min Acceptable deflection from normal values is <65 mmHg significant for hypotension, >110 mmHg for hypertension. | Time 2=5 minutes after discontinuing analgo-sedation and oxygenation (LFNO or HFNO). |
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