Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade

NCT07829094 | Not Yet Recruiting DMC

• 1 other identifier: 388/24
• Study Type: interventional
• Target: 6,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pulmonary Complications

Keywords

Postoperative Complications; Laryngeal Masks; Intubation; Endotracheal Tube; Neuromuscular Blockade; Surgical conditions; Postoperative pulmonary complications; PPC; Anesthesia; Supraglottic airway

Outcome Measures

Primary Outcomes (1)

• Occurrence of at least one postoperative pulmonary complication

  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

Secondary Outcomes (7)

• Intraoperative complications

  During the surgery

• Critical respiratory events in the recovery room

  During post-anesthesia care before admission to the normal ward

• Any postoperative in-hospital complication

  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

  During surgery, assessed every 15 minutes

• Quality of Recovery questionnaire

  On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180

Study Arms (5)

Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)

ACTIVE COMPARATOR

General anesthesia with tracheal tube management and moderate neuromuscular blockade.

Procedure: Airway management strategy; Other: Deep versus moderate neuromuscular blockade (NMB)

Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)

EXPERIMENTAL

General anesthesia with supraglottic airway device management and deep neuromuscular blockade.

Procedure: Airway management strategy; Procedure: Initiation of neuromuscular blockade (NMB); Other: Deep versus moderate neuromuscular blockade (NMB)

Supraglottic Airway Device without Neuromuscular Blockade (SGA/no NMB)

ACTIVE COMPARATOR

General anaesthesia with supraglottic airway device management without neuromuscular blockade.

Procedure: Initiation of neuromuscular blockade (NMB)

Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)

ACTIVE COMPARATOR

General anesthesia with tracheal tube management and deep neuromuscular blockade.

Procedure: Airway management strategy; Other: Deep versus moderate neuromuscular blockade (NMB)

Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)

EXPERIMENTAL

General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.

Procedure: Airway management strategy; Procedure: Initiation of neuromuscular blockade (NMB); Other: Deep versus moderate neuromuscular blockade (NMB)

Interventions

Airway management strategy PROCEDURE

For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.

Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB); Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB); Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB); Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)

Initiation of neuromuscular blockade (NMB) PROCEDURE

For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.

Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB); Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB); Supraglottic Airway Device without Neuromuscular Blockade (SGA/no NMB)

Deep versus moderate neuromuscular blockade (NMB) OTHER

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.

Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB); Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB); Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB); Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Ulm: lead
• Medical University of Vienna: collaborator
• Universitätsmedizin Mannheim: collaborator
• Klinikum Oldenburg gGmbH: collaborator
• University Hospital, Zürich: collaborator
• St. Josef Hospital Bochum: collaborator

Related Publications (7)

• 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.

  PMID: 21544025 BACKGROUND

• 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.

  PMID: 29661384 BACKGROUND

• 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.

  PMID: 33341223 BACKGROUND

• 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.

  PMID: 19681772 BACKGROUND

• 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.

  PMID: 12717124 BACKGROUND

• 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.

  PMID: 27414807 BACKGROUND

• 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.

  PMID: 30224322 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred Blobner, Professor M.D.

  Department of Anesthesiology and Intensive Care Medicine, Ulm University Hospital, Ulm, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Béla-Simon Paschold, M.D. Coordinating Investigator

CONTACT

+49 731 50060390; bela-simon.paschold@uni-ulm.de

Clinical Research Physician

CONTACT

+49 731 50054306

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. The intraoperative anaesthesia team and personnel responsible for intraoperative trial conduct will be unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Anesthesiology and Intensive Care Medicine

Model Details: This is a randomized, controlled, parallel-group trial with three study groups. Participants are allocated to tracheal tube management with neuromuscular blockade (TT/NMB), supraglottic airway device management with neuromuscular blockade (SGA/NMB), or supraglottic airway device management without neuromuscular blockade (SGA/no NMB). Allocation occurs in an unequal ratio of 1:2.9:2.9. Patients receiving NMB are additionally allocated 1:1 to receive either deep or moderate neuromuscular blockade.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share