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Postoperative Pulmonary ComplicationsSupAIRNCT07829094

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

A study testing Airway management strategy, Initiation of neuromuscular blockade (NMB) and Deep versus moderate neuromuscular blockade (NMB) in people with Postoperative Pulmonary Complications, run by University Hospital Ulm.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

SupAIR is an international, multicenter, randomized controlled trial investigating whether airway management and neuromuscular blockade during general anesthesia influence postoperative pulmonary complications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pulmonary Complications
What is being tested?
Airway management strategy, Initiation of neuromuscular blockade (NMB) and Deep versus moderate neuromuscular blockade (NMB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,800 participants
Where
No sites listed yet
Study dates
15 Oct 2026to 1 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Béla-Simon Paschold, M.D. Coordinating Investigator contact

+49 731 50060390

bela-simon.paschold@uni-ulm.de

Clinical Research Physician contact

+49 731 50054306

About this study

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.

Read the detailed description

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:

  1. Tracheal tube with moderate NMB
  2. Tracheal tube with deep NMB
  3. Supraglottic airway device with moderate NMB
  4. Supraglottic airway device with deep NMB
  5. 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.

Being tested
Airway management strategy, Initiation of neuromuscular blockade (NMB), Deep versus moderate neuromuscular blockade (NMB)
Keywords
Postoperative Complications, Laryngeal Masks, Intubation, Endotracheal Tube, Neuromuscular Blockade, Surgical conditions, Postoperative pulmonary complications, PPC, Anesthesia, Supraglottic airway
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Airway management strategyProcedure or surgery

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

  • Initiation of neuromuscular blockade (NMB)Procedure or surgery

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

  • 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.

Study groups in NCT07829094
Study groupRoleWhat they receive
Tracheal Tube with moderate Neuromuscular Blockade (TT/moderate NMB)Active comparatorGeneral anesthesia with tracheal tube management and moderate neuromuscular blockade.
Receives: Procedure: Airway management strategy; Other: Deep versus moderate neuromuscular blockade (NMB)
Supraglottic Airway Device with deep Neuromuscular Blockade (SGA/deep NMB)ExperimentalGeneral anesthesia with supraglottic airway device management and deep neuromuscular blockade.
Receives: 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 comparatorGeneral anaesthesia with supraglottic airway device management without neuromuscular blockade.
Receives: Procedure: Initiation of neuromuscular blockade (NMB)
Tracheal Tube with deep Neuromuscular Blockade (TT/deep NMB)Active comparatorGeneral anesthesia with tracheal tube management and deep neuromuscular blockade.
Receives: Procedure: Airway management strategy; Other: Deep versus moderate neuromuscular blockade (NMB)
Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA/moderate NMB)ExperimentalGeneral anesthesia with supraglottic airway device management and moderate neuromuscular blockade.
Receives: Procedure: Airway management strategy; Procedure: Initiation of neuromuscular blockade (NMB); Other: Deep versus moderate neuromuscular blockade (NMB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier

Secondary outcomes (7)
  1. Intraoperative complications

    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.

    Measured: During the surgery

  2. Critical respiratory events in the recovery room

    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.

    Measured: During post-anesthesia care before admission to the normal ward

  3. Any postoperative in-hospital complication

    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.

    Measured: Patients are visited on postoperative days 1 and 3 to 4 in person and on the day of discharge from hospital or day 28 (whatever occurs first) via chart review to document complications between the current and the last assessment.

  4. Surgical conditions

    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.

    Measured: During surgery, assessed every 15 minutes

  5. Quality of Recovery questionnaire

    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) summing to a maximum of 150 points with greater sum representing better recovery.

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

  6. Functional Health

    The WHODAS-2 (World Health Organization Disability Assessment Schedule 2.0) scale will be used to quantify the level of disability ranging from 0 (no difficulty) to 42 (great difficulty) within the last 30 days.

    Measured: During pre-admission testing and 180 days after surgery

  7. Further Outcomes

    Length of hospital stay, length of intensive care unit stay and 180-day mortality.

    Measured: Retrieved from Chart Review or at the 180 day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07829094
Sponsor's protocol ID
388/24
Acronym
SupAIR
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21544025
  • 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.

    PubMed 29661384
  • 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.

    PubMed 33341223
  • 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.

    PubMed 19681772
  • 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.

    PubMed 12717124
  • 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.

    PubMed 27414807
  • 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.

    PubMed 30224322

Questions about this trial

What is this clinical trial studying?

A study testing Airway management strategy, Initiation of neuromuscular blockade (NMB) and Deep versus moderate neuromuscular blockade (NMB) in people with Postoperative Pulmonary Complications, run by University Hospital Ulm.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Béla-Simon Paschold, M.D. Coordinating Investigator (+49 731 50060390, bela-simon.paschold@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of at least one postoperative pulmonary complication (time frame: Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07829094, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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