Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Hospital Centre Zagreb | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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 micro-endoscopic surgery of posterior eye chamber. Patients usually receive analgo-sedation combined with topical anesthesia, which, depending on the type of surgery, precedes a regional, retrobulbar or sub-Tenon block. Although lower doses of intravenous anesthetics are carefully titrated in continuous infusion and standard, low - flow nasal oxygenation (LFNO) is applied, patients are prone to respiratory insufficiency. Obese patients are especially susceptible to bradypnoea, transitory apnoea, hypoxia and hypercapnia. Respiratory instability is then often followed by circulatory one presented by heart rate and blood pressure deflections from baseline values. It is known that higher anesthesia risk obese patients may suffer from serious complications due to respiratory issues during analgo-sedation, even fatal outcome may occur.
LFNO is applied at rate of 5 L/min O2 per nasal catheter, reaching inspiratory fraction of oxygen (FiO2) of 40%. High-flow nasal oxygenation (HFNO) is an innovative method of patient oxygenation that delivers warmed and moistened oxygen and air mixture with a flow rate of up to 70 L/min and up to 100% FiO2 via specially designed soft nasal cannula. It is known that 40 L/min of oxygen/air mixture delivered by HFNO provides 40% FiO2 applying continuous positive inspiratory pressure of 3-7 cmH2O which ensures continuous non-invasive support of patients' spontaneous ventilation and thus better oxygenation stability of the patient.
OBJECTIVE: The study aims to determine the effect of HFNO versus LFNO on the stability of spontaneous ventilation during standardized intravenous analgo-sedation for PPV in normal weight and obese patients.
HYPOTHESIS: Investigators hypothesize that administration of HFNO in comparison with LFNO in patients with preserved spontaneous breathing during the standard analgo-sedation procedure will contribute to better oxygenation maintenance and, consequently, greater peri-procedural safety of patients, especially in obese patients.
Investigators expect that HFNO will provide reduced bradypnoea intervals (bradypnoea <12 breaths/min, FoB 1/min), longer maintenance of adequate oxygenation, shorter intervals of desaturation (peripheral blood oxygen saturation - SpO2≤92%), reducing hypercapnia (expiratory carbon-dioxide - expCO2≥45 mmHg) and less airway opening maneuvers performed by attending anesthesiologist (AOM). These will prevent partial respiratory insufficiency detected by low SpO2 accompanied by low or normal expiratory carbon-dioxide level (expCO2), and global respiratory insufficiency detected by decreased SpO2≤92% and increased expCO2≥45 mmHg.
Investigators plan to conduct prospective, parallel group, randomized controlled clinical trial. Trial will be managed according to principles of Declaration of Helsinki for scientific clinical research and will be planned and guided according to CONSORT guidelines (Consolidated Standards of Reporting Trials). The trial has been approved by Hospital's Ethic Committee.
The source of information are going to be 126 adult patients scheduled for PPV under analgo-sedation. Eligible participants will be interviewed and examined ambulatory by anesthesiologist, their ASA status, difficulty of airway management and body mass index (BMI) evaluated. After initial examination inclusive and exclusive criteria will be distinguished. Eligible participants who give voluntarily their written consent of participation will be included in this study. After that, participants will be assigned to equal normal weight (18\
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: 18<BMI<30 - LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Active Comparator: 30≤BMI<35 kg/m2 - LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Active Comparator: BMI≥35 kg/m2 - LFNO | Active Comparator | Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40% |
|
| Experimental: 18<BMI<30 kg/m2 - HFNO | Active Comparator | High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| Experimental: 30≤BMI<35 kg/m2 - HFNO | Active Comparator | High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: low-flow nasal oxygenation (LFNO) 18<BMI<30 kg/m2 | Device | Active comparator LFNO: O2 flow 5 L/min, FiO2 40% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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, |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dubravka Bartolek Hamp, Assist.prof. | Contact | 911963033 | +385 | dbartolekh@gmail.com |
| Anita Vukovic, MD | Contact | 989264821 | +385 | anita_vukovic1@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University clinical hospital centre Zagreb | Recruiting | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784208 | Background | Mehta S, Blinder KJ, Shah GK, Grand MG. Pars plana vitrectomy versus combined pars plana vitrectomy and scleral buckle for primary repair of rhegmatogenous retinal detachment. Can J Ophthalmol. 2011 Jun;46(3):237-41. doi: 10.1016/j.jcjo.2011.05.003. Epub 2011 May 27. | |
| 21772988 | Background | Kunikata H, Uematsu M, Nakazawa T, Fuse N. Successful removal of large intraocular foreign body by 25-gauge microincision vitrectomy surgery. J Ophthalmol. 2011;2011:940323. doi: 10.1155/2011/940323. Epub 2011 Apr 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigators plan to conduct prospective, parallel group, randomized controlled clinical trial.
In total, 126 participants will be included in this trial. These participants are patients scheduled for outpatient analgo-sedation for vitrectomy.
Not provided
Not provided
Anesthesiologist who interviews and examines patients scheduled for PPV under analgo-sedation will enroll eligible participants and offer procedure explanation with possibility to sign uniformed written consent. Unique personal hospital admission number (UPHAN) will be assigned to all eligible participants. Participants will be randomized to control or intervention group by using random numbers generator. Anesthesiologist who implements anesthesia will receive nontransparent envelope with assigned intervention provided by independent investigator and will not decide which participant will receive LFNO or HFNO. However, attending anesthesiologist and participants will unavoidably be aware of type of oxygenation applied. Collected data are objective measures. Investigator who collects data after procedure will be unaware of study protocol and will enter data to formatted database. Participants' data will be noted under UPHAN. Outcome assessors will be unaware of intervention applied.
| Experimental: BMI≥35 kg/m2 - HFNO |
| Active Comparator |
High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40% |
|
| Device: low-flow nasal oxygenation (LFNO) 30≤BMI<35 kg/m2 | Device | Active comparator LFNO: O2 flow 5 L/min, FiO2 40% |
|
| Device: low-flow nasal oxygenation (LFNO) BMI≥35 kg/m2 | Device | Active comparator LFNO: O2 flow 5 L/min, FiO2 40% |
|
| Device: High-flow nasal oxygenation (HFNO) 18<BMI<30 kg/m2 | Device | Experimental HFNO: O2 flow 40 L/min, FiO2 40% |
|
| Device: High-flow nasal oxygenation (HFNO) 30≤BMI<35 kg/m2 | Device | Experimental HFNO: O2 flow 40 L/min, FiO2 40% |
|
| Device: High-flow nasal oxygenation (HFNO) BMI≥35 kg/m2 | Device | Experimental HFNO: O2 flow 40 L/min, FiO2 40% |
|
| 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 |
| 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). |
| 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. |
| 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. |
| 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). |
| 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.) |
| 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.) |
| 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.) |
| 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.) |
| Measurement of procedural parameters: duration of awakening (awaken patient). | Duration of awakening (min) - expected duration up to 5 minutes (minutes). | up to 5 minutes |
| 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 |
| 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. |
| 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). |
| 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. |
| 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. |
| 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). |
| 21726843 | Background | Baker PS, Spirn MJ, Chiang A, Regillo CD, Ho AC, Vander JF, Kaiser RS. 23-Gauge transconjunctival pars plana vitrectomy for removal of retained lens fragments. Am J Ophthalmol. 2011 Oct;152(4):624-7. doi: 10.1016/j.ajo.2011.04.003. Epub 2011 Jul 2. |
| 30342778 | Background | 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. |
| 17579505 | Background | Becker DE, Haas DA. Management of complications during moderate and deep sedation: respiratory and cardiovascular considerations. Anesth Prog. 2007 Summer;54(2):59-68; quiz 69. doi: 10.2344/0003-3006(2007)54[59:MOCDMA]2.0.CO;2. |
| 29719796 | Background | 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. |
| 23740356 | Background | Frieling T, Heise J, Kreysel C, Kuhlen R, Schepke M. Sedation-associated complications in endoscopy--prospective multicentre survey of 191142 patients. Z Gastroenterol. 2013 Jun;51(6):568-72. doi: 10.1055/s-0032-1330441. Epub 2013 Jun 5. |
| 26106206 | Background | 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. |
| 28089816 | Background | 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. |
| 20410783 | Background | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available. |
| 27372775 | Background | Jirapinyo P, Thompson CC. Sedation Challenges: Obesity and Sleep Apnea. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):527-37. doi: 10.1016/j.giec.2016.03.001. |
| 26545146 | Background | 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015508 | Nasal Obstruction |
| D012131 | Respiratory Insufficiency |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
Not provided
Not provided