An interventional study of Airway management strategy and Initiation of neuromuscular blockade (NMB) in Postoperative Pulmonary Complications, sponsored by University Hospital Ulm. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University Hospital Ulm · Not applicable, Interventional, and Prevention
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.
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:
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.
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.
General anesthesia with tracheal tube management and moderate neuromuscular blockade.
Procedure: Airway management strategy · Other: Deep versus moderate neuromuscular blockade (NMB)
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)
General anaesthesia with supraglottic airway device management without neuromuscular blockade.
Procedure: Initiation of neuromuscular blockade (NMB)
General anesthesia with tracheal tube management and deep neuromuscular blockade.
Procedure: Airway management strategy · Other: Deep versus moderate neuromuscular blockade (NMB)
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)
For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.
For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway 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.
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
Time frame: Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier
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.
Time frame: During the surgery
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.
Time frame: During post-anesthesia care before admission to the normal ward
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.
Time frame: 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
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.
Time frame: During surgery, assessed every 15 minutes
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).
Time frame: On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180
Functional Health
The WHODAS-2 (World Health Organization Disability Assessment Schedule 2.0) scale will be used to quantify the level of disability.
Time frame: On the day of admission and 180 days after surgery
Further Outcomes
Length of hospital stay, length of intensive care unit stay and 180-day mortality.
Time frame: Retrieved from Chart Review or at the 180 day follow-up
No study locations are listed for this record.
Plan to share: No
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University Hospital Ulm