Influence of HFNO on Spontaneous Ventilation in Patients of Different ASA Risk During Analgo-sedation for Vitrectomy

NCT04055077 | Unknown

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

Brief Summary

Pars plana vitrectomy is minimally invasive endoscopic procedure which is usually performed in moderate analgo-sedation given by anesthesiologist combined with topical anesthesia and retrobulbar or Subtenon block performed by surgeon. Intravenously applied anesthetics can often lead to slower breathing rate or cessation of breathing which introduces risk of low blood oxygen level despite careful adjustment of anesthetics' dose and application of standard low-flow nasal oxygenation (LFNO). Respiratory instability is often accompanied by circulatory instability manifested by disturbances of heart rate and blood pressure. LFNO provides maximally 40% inspired fraction of oxygen and can cause discomfort of a patient due to coldness and dryness of inspired gas. On the other hand, high-flow nasal oxygenation (HFNO) can bring up to 100% of inspired oxygen fraction to patient, providing noninvasive pressure support of 3-7 cmH2O in patients' upper airway which ensures better oxygenation especially in higher anesthesia risk patients. Because of carrying warmed and humidified air/oxygen mixture via soft nasal cannula, HFNO is better tolerated by patients. In this trial investigators will compare effect of HFNO to LFNO during intravenously applied standardized analgo-sedation given for vitrectomy in normal weight patients of low and high anesthesia risk. Investigators hypothesize that normal weight patients of low and high anesthesia risk, whose breathing pattern is preserved, receiving HFNO vs. LFNO during standardized analgo-sedation for vitrectomy will be more respiratory and circulatory stable, preserving normal blood O2 and CO2 level, breathing pattern, heart rate and blood pressure.

Conditions

Noninvasive Ventilation; Respiratory Insufficiency; Moderate Sedation; Hypoxia; Airway Management; Vitrectomy

Keywords

Noninvasive Ventilation; Airway management; Vitrectomy; Adult; Moderate Sedation; Hypoxia

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)

ASA I/LFNO

ACTIVE COMPARATOR

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

Device: Low-flow nasal oxygenation (LFNO) ASA I

ASA II/LFNO

ACTIVE COMPARATOR

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

Device: Low-flow nasal oxygenation (LFNO) ASA II

ASA III/LFNO

ACTIVE COMPARATOR

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

Device: Low-flow nasal oxygenation (LFNO) ASA III

ASA I/HFNO

EXPERIMENTAL

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

Device: High-flow nasal oxygenation (HFNO) ASA I

ASA II/HFNO

EXPERIMENTAL

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

Device: High-flow nasal oxygenation (HFNO) ASAII

ASA III/HFNO

EXPERIMENTAL

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

Device: High-flow nasal oxygenation (HFNO) ASA III

Interventions

Low-flow nasal oxygenation (LFNO) ASA I DEVICE

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

ASA I/LFNO

Low-flow nasal oxygenation (LFNO) ASA II DEVICE

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

ASA II/LFNO

Low-flow nasal oxygenation (LFNO) ASA III DEVICE

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

ASA III/LFNO

High-flow nasal oxygenation (HFNO) ASA I DEVICE

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

ASA I/HFNO

High-flow nasal oxygenation (HFNO) ASAII DEVICE

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

ASA II/HFNO

High-flow nasal oxygenation (HFNO) ASA III DEVICE

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

ASA III/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 ASA patients of risk class I, II and III
• moderate intravenous analgo-sedation
• pars plana vitrectomy

You may not qualify if:

• Conventional vitrectomy
• Obese
• Diseases of peripheral blood vessels
• Hematological diseases
• Psychiatric diseases
• Sideropenic anaemia
• 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, Croatia

Zagreb, 10000, Croatia

RECRUITING

Related Publications (8)

• 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

• 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

• Frat JP, Goudet V, Girault C. [High flow, humidified-reheated oxygen therapy: a new oxygenation technique for adults]. Rev Mal Respir. 2013 Oct;30(8):627-43. doi: 10.1016/j.rmr.2013.04.016. Epub 2013 May 29. French.

  PMID: 24182650 BACKGROUND

• Booth AWG, Vidhani K, Lee PK, Thomsett CM. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth. 2017 Mar 1;118(3):444-451. doi: 10.1093/bja/aew468.

  PMID: 28203745 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

• Morris K. Revising the Declaration of Helsinki. Lancet. 2013 Jun 1;381(9881):1889-90. doi: 10.1016/s0140-6736(13)60951-4. No abstract available.

  PMID: 23734387 BACKGROUND

• Moher D, Schulz KF, Altman DG; CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Investig. 2003 Mar;7(1):2-7. doi: 10.1007/s00784-002-0188-x. Epub 2003 Jan 31.

  PMID: 12673431 BACKGROUND

Related Links

• American Society of Anesthesiologists (ASA). ASA physical status classification system 2014 Oct \[internet\]. schaumburg, Illinois, USA: ASA;2014.
• Interactive Statistical Pages \[internet\]. USA: Statpages.net;c2019 \[cited 2019 Aug1\]
• Programiz \[internet\]. Kupandole, Nepal: Parewa Labs Pvt. Ltd \[cited 2019 Aug 1\]. Flowchart in programming.

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 analgo-sedation for vitrectomy.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 13, 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)