Background: Postoperative pulmonary complications are frequent postoperative problems that occur following abdominal surgery and are linked to elevated morbidity and mortality, as well as, the utilization of hospital resources One of the potentially adjustable variables affecting the occurrence of early respiratory events is the extubation position, which is still a normal practice in most operating rooms in the traditional flat supine position. The positioning of Semi Fowler (head-up) can increase diaphragmatic mechanics, gas exchange and airway protection than supine positioning . Methods: It is a sample of 150 adults (18 to 65 years) undergoing elective abdominal surgery with general anesthesia randomized either with extubation and early recovery in the PACU in the supine position (0 degree) or the semi-Fowler position (head-of-bed elevation to 30 degree). The primary outcome in 30 minutes was airway obstruction requiring intervention (jaw thrust/oropharyngeal airway), assisted ventilation and persistent tachypnea with accessory muscle effort or increase in rescue oxygen demand to maintain SpO2 promoted to greater than 94%. Hypoxemia (SpO2 below 92 percent throughout over 30 seconds) and hypothetical aspiration were considered as secondary safety observations (observations descriptive). Results: All the randomized subjects were assessed (75 each). There were no differences in baseline demographics, ASA class, type and length of surgery between groups. In the supine group (18.7% vs. 5/75 (6.7%)) versus the semi-Fowlers group (risk ratio [RR] 0.36; 95% CI 0.140.94; p=0.03): in the supine group it was 14/75 (18.7%), vs. 5/75 (6.7%), respiratory distress. Mean PACU SpO2 PACU positions were more preferential to semi-Fowlers position (6/75 [8.0%] versus 12/ 75 [16.0%]) and had less incidences of hypoxemia. Suspected aspiration was rare (0 vs 2) cases. Conclusion: Semi-Fowler’s positioning (30°) during extubation and early recovery significantly reduced early respiratory distress after abdominal surgery and showed favorable descriptive trends for reduced hypoxemia. This low-cost intervention is readily implementable in routine PACU workflows.
Consequently, the current randomized controlled trial had one main goal: to compare the results of extubation in supine and semi-Fowler position among adults who undergo elective abdominal surgeries during general anesthesia in terms of early post-extubation respiratory compromise (respiratory distress, hypoxemia, aspiration).
Study design, setting, and duration A single-center, prospective, parallel-group randomized controlled study was conducted over 6 months in the operating rooms and PACU of R.L. Jalappa Hospital and Research Centre, Tamaka, Kolar, India. Participants Adult patients aged 18–65 years with ASA physical status I–II scheduled for elective abdominal surgery under general anesthesia were screened. Inclusion criteria: 1. Age 18–65 years; 2) ASA I–II; 3) elective abdominal surgery requiring endotracheal intubation. Exclusion criteria: 1. Pre-existing respiratory disease (e.g., COPD, uncontrolled asthma, restrictive lung disease); 2) contraindication to head-of-bed elevation (e.g., hemodynamic instability, spinal precautions); 3) anticipated difficult airway requiring nonstandard extubation strategy; 4) emergency surgery. Ethics. Institutional ethics committee approval was obtained before initiation, and written informed consent was obtained during pre-anesthetic evaluation. The study was reported in accordance with CONSORT principles. Randomization and allocation concealment Block randomization (variable block sizes of 4 and 6) generated a 1:1 allocation sequence by an investigator not involved in outcome assessment. Sequentially numbered, opaque, sealed envelopes were opened immediately before planned emergence. Perioperative management Even the patients were provided with standardized care (ECG, non-invasive blood pressure, pulse oximetry). Intravenous opioid and hypnotic agent induced general anesthesia according to departmental protocol and was maintained by inhalational anesthesia administration encompassing neuromuscular blockage habitually. The anticholinesterase/anticholinergic agents were used to reverse neuromuscular blockade at the end of surgery as soon as the clinical criteria were achieved. The case of extubation was conducted according to the standard criteria (sufficient spontaneous ventilation, purposeful response, presence of airway reflexes, hemodynamic stability). Interventions • Supine group: extubation performed at 0° head elevation; patient remained supine for the first 30 minutes in PACU. • Semi-Fowler’s group: extubation performed at 30° head-of-bed elevation (verified using bed angle scale); position maintained for the first 30 minutes in PACU. All patients received supplemental oxygen immediately after extubation (face mask per PACU protocol) with escalation permitted if clinically indicated. Outcomes Primaryoutcome: Respiratory distress within 30 minutes post-extubation, defined as any of the following: 1. airway obstruction requiring jaw thrust and/or airway adjunct; 2. assisted ventilation (bag-mask) for hypoventilation/obstruction; 3. tachypnea with accessory muscle use requiring clinician intervention; 4. escalation of oxygen therapy beyond routine PACU flow to maintain SpO₂ ≥94%. Secondary observations: • Hypoxemia (SpO₂ <92% for >30 seconds), • Suspected aspiration (new cough/wheeze with regurgitation or particulate matter; or new oxygen requirement with witnessed regurgitation). Respiratory rate, SpO₂, heart rate, and blood pressure were recorded at extubation (T0) and at 5, 10, 20, and 30 minutes in PACU. Sample size To compare two proportions based on a two-sided 10.5 alpha and 80% power, sample size was determined. Adverse respiratory event rates Baseline reported adverse respiratory event are nearly 20 percent in observational cohorts. A clinically important change of 5 per cent with semi-Fowler positioning was assumed and therefore 75 participants in each group (n=150 overall) were needed (Charan and Biswas methodology). Statistical analysis The intention-to-treat principle was used in analysis. The summary of categorical variables was obtained as counts and percentages, the summary of continuous variables was obtained as mean (SD) or median (IQR) as necessary. The main outcome (incidence of respiratory distress) was analyzed with the help of the chi-square test, and the effect sizes were reported as RR, absolute risk difference, and 95% intervals. The statistically significant case was only achieved at two-sided p<0.05.
Main findings
One hundred and sixty-eight patients were evaluated as eligible; 150 of them were randomized (75 in each group). Every participant, who was assigned at random, did the 30 minutes PACU observation and was incorporated in the main analysis (Figure 1). Demographic and surgical baseline factors were well matched across groups (Table 1), as the age, sex, and ASA class were equally distributed, as well as procedures.
Early post-extubation respiratory distress was reduced in the group of semi-Fowler. The incidence of respiratory distress among supine patients (18.7% versus semi-Fowlers 6.7 percent) had a relative risk ratio of about 64% less (Table 3). The supine group had the most frequent clinical phenotype of the distress phenotype with upper airway blockage that necessitated jaw thrust/airway adjunct and intermittent ventilatory support.
Table 4 supported the secondary observations with fewer hypoxemia and fewer events with aspiration in the semi-Fowler group. Mean SpO2 patterns during the initial 30 minutes were slightly greater in the semi-Fowler arm, and the rise in oxygen therapy was not as common (Table 2; Figure 2), which were not pre-specified to test the hypothesis.
Table 1. Baseline characteristics and operative profile (n=150)
|
Variable |
Supine (n=75) |
Semi-Fowler’s (n=75) |
p-value |
|
Age, years (mean ± SD) |
44.2 ± 11.6 |
43.7 ± 12.1 |
0.797† |
|
Female sex, n (%) |
34 (45.3) |
33 (44.0) |
0.870‡ |
|
BMI, kg/m² (mean ± SD) |
24.9 ± 3.6 |
25.1 ± 3.5 |
0.731† |
|
ASA I, n (%) |
46 (61.3) |
48 (64.0) |
0.736‡ |
|
Open abdominal surgery, n (%) |
42 (56.0) |
40 (53.3) |
0.743‡ |
|
Duration of surgery, min (mean ± SD) |
108 ± 34 |
111 ± 36 |
0.601† |
The two randomized groups were similar at baseline. Age, sex distribution, BMI, and ASA physical status were structured well, which restricted the confounding of preoperative risk. There was also similarity in the operative exposure, as that very early indications of respiratory variations showed an open/laparoscopic approach and the mean duration of operation and this assertion is in accord with the presumption of early recovery respiratory variations, but not case-mix imbalance.
Table 2. Early PACU respiratory physiology and interventions (first 30 minutes)
|
Measure |
Supine (n=75) |
Semi-Fowler’s (n=75) |
p-value |
|
SpO₂ at 5 min, % (mean ± SD) |
95.6 ± 2.3 |
96.4 ± 2.0 |
0.024† |
|
SpO₂ at 30 min, % (mean ± SD) |
96.2 ± 1.9 |
97.0 ± 1.6 |
0.006† |
|
RR at 10 min, breaths/min (mean ± SD) |
19.8 ± 4.2 |
18.7 ± 3.9 |
0.099† |
|
Escalation above routine O₂ flow, n (%) |
13 (17.3) |
6 (8.0) |
0.086‡ |
|
Airway adjunct used n (%) |
10 (13.3) |
4 (5.3) |
0.092‡ |
The use of semi-Fowler was linked to slightly greater average values of SpO2 and reduced early rise of recovery enhancement in oxygen support. It had a coherent clinical pattern: there were decreased airway adjuncts requirements and reduced oxygen escalations that are all indicative of enhanced airway openness and functional residual volume of the airways in a head-up posture at emergence. Although these supporting interventions were not aimed as primary outcomes, they are parallel to the results of the respiratory distress events observed.
Table 3. Primary outcome—Respiratory distress within 30 minutes
|
Outcome |
Supine (n=75) |
Semi-Fowler’s (n=75) |
Effect |
p-value |
|
Respiratory distress, n (%) |
14 (18.7) |
5 (6.7) |
RR 0.36 (95% CI 0.14–0.94) |
0.027‡ |
The semi-Fowler approach achieved a statistically significant, clinical meaningful, decrease in the early respiratory distress. The risk reduction of 12 percent would suggest that the placement of some nine or so patients head-up on the occasion of extubation would avoid one instance of the occurrence of clinically significant distress necessitating intervention. The RR confidence interval indicates that the benefit is probably not a trivial one and that the intervention is recommended as a low-cost, workflow compatible intervention to achieve safety in abdominal surgery recovery.
Table 4. Secondary observations
|
Event |
Supine (n=75) |
Semi-Fowler’s (n=75) |
p-value |
|
Hypoxemia (SpO₂ <92% >30 s), n (%) |
12 (16.0) |
6 (8.0) |
0.132‡ |
|
Suspected aspiration, n (%) |
2 (2.7) |
0 (0.0) |
0.497§ |
|
Reintubation, n (%) |
0 (0.0) |
0 (0.0) |
1.000§ |
Whereas not powered to test a hypothesis, the pattern of secondary events was more consistent with the positioning of semi-Fowler who had a frequency ratio about half as high of hypoxemia episodes that were observed and no events which were consistent with aspiration found in the head-up arm. The minimal aspiration rates are anticipated in elective cohorts of ASA I and ASA II and are to be heeded with care. The direction of the effect, however, is biologically possible in view of the established effect of reflux/aspiration risk and the gas exchange based on body position.
Figure
FIGURE 1.EARLY RESPIRATORY EVENTS
Recruiting and retention were robust, and all of the randomized participants finished the initial PACU observation, and participated in the initial analysis. Lack of post randomization exclusions minimizes the impact of attrition bias, and enhances internal validity. The flow also promotes the pragmatic feasibility: the head-of-bed elevation at the time of extubation needed no special equipments and did not mixed up the protocol compliance within the normal operating room and PACU routine operations.
FIGURE 2. PRIMARY OUTCOME VISUALIZATION—RESPIRATORY DISTRESS INCIDENCE BY GROUP
The effect size between groups is both large and visually significant and in line with the clinically important effect size. There is a significant decrease in the number of distress events associated with the semi-Fowler arm, which can be attributed to the number of airway maneuvers and the number of rescue respiratory support. The most significant approach to curtailing the frequency of these initial destabilizing instances in recovery regions where the quantity of staffing and monitoring is variable is the implementation of reducing the frequency of the events, which may yield smoother PACU throughput and less downstream escalation, which is consistent with the broader findings that positioning can meaningfully impact post-extubation oxygenation.
In adults who had an elective abdominal surgery, the use of extubation and early PACU recovery in a 30o semi-Fowler position substantially decreased early postoperative respiratory distress as compared with traditional supine position. The clinical significance of the effect was significant and obtained with a low cost intervention that involved no extra equipment or pharmacologic modification. Even the descriptive trends indicated less incidence of hypoxemia and absence of events corroborated by aspiration in the head up group albeit such observations require bigger confirmatory samples. Adopting the positioning described by semi-Fowler at the moment of emergence can be a feasible, scalable improvement on PACU respiratory safety protocols in patients undergoing regular abdominal surgery.