Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade (SupAIR)
SupAIR is an international, multicenter, randomized controlled trial investigating whether airway management and neuromuscular blockade during general anesthesia influence postoperative pulmonary complications.
Approximately 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms: tracheal intubation with moderate neuromuscular blockade, tracheal intubation with deep neuromuscular blockade, supraglottic airway with moderate neuromuscular blockade, supraglottic airway with deep neuromuscular blockade, or supraglottic airway without neuromuscular blockade.
The primary outcome is the occurrence of postoperative pulmonary complications during the hospital stay. Secondary outcomes include perioperative complications, surgical conditions, recovery, and functional health. Participants will be followed during hospitalization and again approximately six months after surgery.
Přehled studie
Postavení
Podmínky
Detailní popis
SupAIR is an international, multicenter, randomized, controlled, parallel-group clinical trial evaluating the effects of airway management and neuromuscular blockade (NMB) on postoperative pulmonary complications after general anesthesia.
A total of 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms:
- Tracheal tube with moderate NMB
- Tracheal tube with deep NMB
- Supraglottic airway device with moderate NMB
- Supraglottic airway device with deep NMB
- Supraglottic airway device without NMB
The five treatment arms result from an initial allocation to tracheal tube with NMB, supraglottic airway device with NMB, or supraglottic airway device without NMB. Participants assigned to NMB are additionally randomized to moderate or deep neuromuscular blockade.
The study addresses two primary hypotheses. First, among participants receiving NMB, use of a supraglottic airway device is hypothesized to reduce postoperative pulmonary complications compared with tracheal intubation. Second, among participants managed with a supraglottic airway device, the use of NMB is hypothesized not to increase postoperative pulmonary complications compared with no NMB. Finally, among participants receiving NMB depth of neuromuscular blockade will be used as secondary exposure.
The randomized intervention determines airway management and the use and depth of neuromuscular blockade. Quantitative neuromuscular monitoring is used in participants receiving NMB, and recovery from neuromuscular blockade is managed according to applicable clinical guidelines. All other aspects of perioperative anesthetic management are performed according to local clinical practice.
The primary outcome is the occurrence of at least one postoperative pulmonary complication from postoperative day 1 until hospital discharge or postoperative day 28, whichever occurs first. The composite includes respiratory failure, suspected pulmonary infection, pulmonary infiltrates, atelectasis, aspiration pneumonitis, bronchospasm, and pulmonary oedema.
Postoperative outcomes are assessed by blinded study personnel during the hospital stay. Secondary outcomes include intraoperative and postoperative complications, respiratory events in the post-anesthesia care unit, surgical conditions, quality of recovery, functional health, length of stay, intensive care treatment, and mortality. Participants are additionally followed by telephone approximately six months after surgery.
An interim analysis is planned after approximately 1,000 participants to assess assumptions relevant to sample-size planning. Interim results will be reviewed by the independent Data and Safety Monitoring Board, and the total sample size may be adjusted in accordance with the prespecified analysis plan.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Béla-Simon Paschold, M.D. Coordinating Investigator
- Telefonní číslo: +49 731 50060390
- E-mail: bela-simon.paschold@uni-ulm.de
Studijní záloha kontaktů
- Jméno: Clinical Research Physician
- Telefonní číslo: +49 731 50054306
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Adult patients (≥ 18 years) with an ASA physical status ≤ 3 scheduled for elective non-cardiac surgery under general anaesthesia whose airway can be secured via tracheal tube or SGA.
Exclusion Criteria:
Contraindications for using supraglottic devices, tracheal tube, or neuromuscular blocking agents (and reversal drugs); surgery in prone positioning; surgical procedures scheduled outside the operating room; ambulatory surgery; pregnancy; patients planned for consecutive anaesthetic/surgical procedures in the following 14 days or within the past 14 days.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)
General anesthesia with tracheal tube management and moderate neuromuscular blockade.
|
For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
Deep or moderate NMB.
Muscle relaxants are administered according to group allocation.
Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.
|
|
Experimentální: Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)
General anesthesia with supraglottic airway device management and deep neuromuscular blockade.
|
For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
Deep or moderate NMB.
Muscle relaxants are administered according to group allocation.
Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.
For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.
|
|
Aktivní komparátor: Supraglottic Airway Device without Neuromuscular Blockade (SGA/no NMB)
General anaesthesia with supraglottic airway device management without neuromuscular blockade.
|
For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.
|
|
Aktivní komparátor: Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)
General anesthesia with tracheal tube management and deep neuromuscular blockade.
|
For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
Deep or moderate NMB.
Muscle relaxants are administered according to group allocation.
Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.
|
|
Experimentální: Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)
General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.
|
For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
Deep or moderate NMB.
Muscle relaxants are administered according to group allocation.
Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.
For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Occurrence of at least one postoperative pulmonary complication
Časové okno: Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier
|
The primary outcome is a composite endpoint of postoperative pulmonary complications.
It is met if a participant experiences at least one predefined postoperative pulmonary complication and their severity is graded according to the Clavien-Dindo-Classification
|
Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Intraoperative complications
Časové okno: During the surgery
|
The classification of intraoperative adverse events (ClassIntra), ranging from grade 0 to grade V.
It is used to assess intraoperative anaesthesia- and surgery-related complications.
|
During the surgery
|
|
Critical respiratory events in the recovery room
Časové okno: During post-anesthesia care before admission to the normal ward
|
The outcome is met if at least one predefined critical respiratory event occurs.
Events include upper airway obstruction requiring intervention, hypoxaemia not responding to active interventions, signs of respiratory distress or impending ventilatory failure, inability to breathe deeply, symptoms of respiratory or upper-airway muscle weakness, suspected pulmonary aspiration, or reintubation.
|
During post-anesthesia care before admission to the normal ward
|
|
Any postoperative in-hospital complication
Časové okno: Patients are visited on postoperative days 1, 3, 5, 8, 15 and on the day of discharge from hospital or day 28 (whatever occurs first) to document complications between the current and the last visit.
|
Postoperative complications are recorded during the hospital stay during predefined visits in accordance with the postoperative morbidity survey including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound and pain).
If a complication occurs each complication is categorized according to the Clavien-Dindo classification.
|
Patients are visited on postoperative days 1, 3, 5, 8, 15 and on the day of discharge from hospital or day 28 (whatever occurs first) to document complications between the current and the last visit.
|
|
Surgical conditions
Časové okno: During surgery, assessed every 15 minutes
|
Surgical conditions will be assessed in a single-blinded manner via the Leiden Surgical Rating Scale which ranges from 1 to 5, with 1 indicating extremely poor surgical conditions and 5 indicating optimal surgical conditions considering visibility, surgical space, muscle contractions, handling tactics and patient movement.
|
During surgery, assessed every 15 minutes
|
|
Quality of Recovery questionnaire
Časové okno: On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180
|
The Quality of Recovery 15 questionnaire will be assessed and consists of 15 items to determine subjective recovery after surgery on an 11-point Likert scale (0-10).
|
On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180
|
|
Functional Health
Časové okno: On the day of admission and 180 days after surgery
|
The WHODAS-2 (World Health Organization Disability Assessment Schedule 2.0) scale will be used to quantify the level of disability.
|
On the day of admission and 180 days after surgery
|
|
Further Outcomes
Časové okno: Retrieved from Chart Review or at the 180 day follow-up
|
Length of hospital stay, length of intensive care unit stay and 180-day mortality.
|
Retrieved from Chart Review or at the 180 day follow-up
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Manfred Blobner, Professor M.D., Department of Anesthesiology and Intensive Care Medicine, Ulm University Hospital, Ulm, Germany
Publikace a užitečné odkazy
Obecné publikace
- Canet J, Hardman J, Sabate S, Langeron O, Abreu MG, Gallart L, Belda J, Markstaller K, Pelosi P, Mazo V. PERISCOPE study: predicting post-operative pulmonary complications in Europe. Eur J Anaesthesiol. 2011 Jun;28(6):459-61. doi: 10.1097/EJA.0b013e328344be2d. No abstract available.
- Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
- Mencke T, Echternach M, Kleinschmidt S, Lux P, Barth V, Plinkert PK, Fuchs-Buder T. Laryngeal morbidity and quality of tracheal intubation: a randomized controlled trial. Anesthesiology. 2003 May;98(5):1049-56. doi: 10.1097/00000542-200305000-00005.
- Kirmeier E, Eriksson LI, Lewald H, Jonsson Fagerlund M, Hoeft A, Hollmann M, Meistelman C, Hunter JM, Ulm K, Blobner M; POPULAR Contributors. Post-anaesthesia pulmonary complications after use of muscle relaxants (POPULAR): a multicentre, prospective observational study. Lancet Respir Med. 2019 Feb;7(2):129-140. doi: 10.1016/S2213-2600(18)30294-7. Epub 2018 Sep 14.
- Hammer M, Santer P, Schaefer MS, Althoff FC, Wongtangman K, Frey UH, Xu X, Eikermann M, Fassbender P. Supraglottic airway device versus tracheal intubation and the risk of emergent postoperative intubation after general anaesthesia in adults: a retrospective cohort study. Br J Anaesth. 2021 Mar;126(3):738-745. doi: 10.1016/j.bja.2020.10.040. Epub 2020 Dec 17.
- Abdi W, Amathieu R, Adhoum A, Poncelet C, Slavov V, Kamoun W, Combes X, Dhonneur G. Sparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA Supreme and the ETT. Acta Anaesthesiol Scand. 2010 Feb;54(2):141-6. doi: 10.1111/j.1399-6576.2009.02095.x. Epub 2009 Aug 13.
- Xu R, Lian Y, Li WX. Airway Complications during and after General Anesthesia: A Comparison, Systematic Review and Meta-Analysis of Using Flexible Laryngeal Mask Airways and Endotracheal Tubes. PLoS One. 2016 Jul 14;11(7):e0158137. doi: 10.1371/journal.pone.0158137. eCollection 2016.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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