Effect of HFNO on Spontaneous Ventilation in Obese Patients During Analgo-sedation for Vitrectomy

NCT04049240 | Unknown

• 1 other identifier: 8.1-19/188-1B
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedation Complication; Obesity; Hypoxic Respiratory Failure; Airway Obstruction, Nasal; Respiratory Insufficiency; Apnea

Keywords

Noninvasive Ventilation; Obesity; Moderate sedation; Adult; High-flow nasal oxygenation; Vitrectomy; Airway management

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (17)

• Maintaining of expiratory efficiency of spontaneous breathing below hypercapnia value. Measure: expiratory level of CO2 (expCO2) before oxygenation by LFNO or HFNO.

  Time 0=before oxygenation by LFNO or HFNO

• Maintaining of expiratory efficiency of spontaneous breathing below hypercapnia value. Measure: expiratory level of CO2 (expCO2) 15 minutes after institution of LFNO or HFNO.

  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).

  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.

  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.

  Time 1=15 minutes after institution of LFNO or HFNO.

Study Arms (6)

Active Comparator: 18<BMI<30 - LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: Device: low-flow nasal oxygenation (LFNO) 18<BMI<30 kg/m2

Active Comparator: 30≤BMI<35 kg/m2 - LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: Device: low-flow nasal oxygenation (LFNO) 30≤BMI<35 kg/m2

Active Comparator: BMI≥35 kg/m2 - LFNO

ACTIVE COMPARATOR

Low-flow nasal oxygenation (LFNO) O2 flow 5L/min, FiO2 40%

Device: Device: low-flow nasal oxygenation (LFNO) BMI≥35 kg/m2

Experimental: 18<BMI<30 kg/m2 - HFNO

ACTIVE COMPARATOR

High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: Device: High-flow nasal oxygenation (HFNO) 18<BMI<30 kg/m2

Experimental: 30≤BMI<35 kg/m2 - HFNO

ACTIVE COMPARATOR

High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: Device: High-flow nasal oxygenation (HFNO) 30≤BMI<35 kg/m2

Experimental: BMI≥35 kg/m2 - HFNO

ACTIVE COMPARATOR

High Flow nasal oxygenation (HFNO) O2 flow 40L/min, FiO2 40%

Device: Device: High-flow nasal oxygenation (HFNO) BMI≥35 kg/m2

Interventions

Device: low-flow nasal oxygenation (LFNO) 18<BMI<30 kg/m2 DEVICE

Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Active Comparator: 18<BMI<30 - LFNO

Device: low-flow nasal oxygenation (LFNO) 30≤BMI<35 kg/m2 DEVICE

Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Active Comparator: 30≤BMI<35 kg/m2 - LFNO

Device: low-flow nasal oxygenation (LFNO) BMI≥35 kg/m2 DEVICE

Active comparator LFNO: O2 flow 5 L/min, FiO2 40%

Active Comparator: BMI≥35 kg/m2 - LFNO

Device: High-flow nasal oxygenation (HFNO) 18<BMI<30 kg/m2 DEVICE

Experimental HFNO: O2 flow 40 L/min, FiO2 40%

Experimental: 18<BMI<30 kg/m2 - HFNO

Device: High-flow nasal oxygenation (HFNO) 30≤BMI<35 kg/m2 DEVICE

Experimental HFNO: O2 flow 40 L/min, FiO2 40%

Experimental: 30≤BMI<35 kg/m2 - HFNO

Device: High-flow nasal oxygenation (HFNO) BMI≥35 kg/m2 DEVICE

Experimental HFNO: O2 flow 40 L/min, FiO2 40%

Experimental: BMI≥35 kg/m2 - HFNO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

University clinical hospital centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

Related Publications (12)

• 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.

  PMID: 21784208 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.

  PMID: 21772988 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.

  PMID: 21726843 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.

  PMID: 30342778 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.

  PMID: 17579505 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.

  PMID: 29719796 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.

  PMID: 23740356 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.

  PMID: 26106206 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.

  PMID: 28089816 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.

  PMID: 20410783 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.

  PMID: 27372775 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.

  PMID: 26545146 BACKGROUND

Related Links

• American Society of Anesthesiologists (ASA). ASA physical status classification system 2014 Oct \[internet\]. Schaumburg, Illinois, USA: ASA;2014.
• Programiz \[internet\]. Kupandole, Nepal: Parewa Labs Pvt. Ltd \[cited 2019 Aug 1\]. Flowchart in programming.

MeSH Terms

Conditions

Obesity; Nasal Obstruction; Respiratory Insufficiency; Apnea

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory

Central Study Contacts

Dubravka Bartolek Hamp, Assist.prof.

CONTACT

911963033; dbartolekh@gmail.com

Anita Vukovic, MD

CONTACT

989264821; anita_vukovic1@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, specialist of anesthesiology, reanimatology and intensive care

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: August 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)