Trial Outcomes & Findings for Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy (NCT NCT03357393)
NCT ID: NCT03357393
Last Updated: 2021-01-05
Results Overview
Post Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
2 hours after bronchoscopy is finished
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Midazolam and Morphine-scopolamine
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=50 Participants
|
69 years
n=50 Participants
|
68 years
n=50 Participants
|
69 years
n=150 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
72 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
78 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
150 participants
n=150 Participants
|
PRIMARY outcome
Timeframe: 2 hours after bronchoscopy is finishedPost Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours.
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours
|
19 Participants
|
30 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the evening on the day of bronchoscopy. It takes approximately 2 minutes to complete the questionnaire.Post-discharge Surgical Recovery Scale (S-PSR) The modified Swedish version S-PSR is based on the "Post-discharge Surgical Recovery Scale" and is a 14-item questionnaire to assess the recovery post-discharge regarding the patients' health status and activity (see further appendix 2). Each item is rated using a semantic differential scale and the total sum is multiplied by 100. The possible range is 10-100, with higher score indicating a more favourable postoperative recovery.
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Assessment of Self-rated Patient Questionaries' Using S-PSR
|
55 units on a scale
Interval 36.0 to 77.0
|
56 units on a scale
Interval 43.0 to 73.0
|
54 units on a scale
Interval 41.0 to 100.0
|
SECONDARY outcome
Timeframe: The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the morning the day after bronchoscopy. It takes less than 1 minute to complete the assessment.Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery. The questionnaire "Quality of Recovery" (QoR-23) is a 23 item questionnaire to assess recovery after day surgery regarding the patients' emotional state, physical comfort and physical independence (see further appendix 4). Each item is rated on a five-point scale (1-5) and the scores are summed.
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Quality of Recovery (QoR-23)
|
100 score on a scale
Interval 61.0 to 112.0
|
102 score on a scale
Interval 60.0 to 115.0
|
100 score on a scale
Interval 63.0 to 115.0
|
SECONDARY outcome
Timeframe: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.overall satisfaction with the procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied). The patient may comment any cause which made the satisfaction score high or low and if the patient would like to receive the same method of sedation during a future bronchoscopy.
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Patients' Satisfaction Using a Likert-type Scale
|
5 units on a scale
Interval 2.0 to 5.0
|
5 units on a scale
Interval 4.0 to 5.0
|
5 units on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: Directly after completion of the procedure.the bronchoscopist assess their perception of cough, bronchial secretion respectively circumstances for a smooth performance of the bronchoscopy of procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied).
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Bronchoscopist Evaluation Using a Likert-type Scale
|
5 units on a scale
Interval 2.0 to 5.0
|
4 units on a scale
Interval 1.0 to 5.0
|
4 units on a scale
Interval 2.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.Level of sedation is assessed every 5th minute during the procedure by the nurse anaesthetist using The Observer's Assessment of Alertness/Sedation (OAA/S) scale whereby a higher score represent a lighter sedation. Below is the scale descriped, Observation/score: Responds readily to name spoken in normal tone/5 Lethargic response to name spoken in normal tone/4 Responds only after name is called loudly and/or repeatedly/3 Responds only after mild prodding or shaking/2 Does not respond to mild prodding or shaking/1
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
|
3 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.Number of participants with interventions performed to maintain cardiovascular (if atropine or ephidrine has been given) and respiratory stability (if assisted ventilation, chin lift or painful stimulation has been performed). Assesed every five minutes during the procedure.
Outcome measures
| Measure |
Midazolam and Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 Participants
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Number of Participants With Interventions Performed
|
1 Participants
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.Outcome measures
Outcome data not reported
Adverse Events
Midazolam and Morphine-scopolamine
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
PCS (Propofol) With Morphine-scopolamine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PCS (Propofol) With Glycopyrronium Bromide
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Midazolam and Morphine-scopolamine
n=50 participants at risk
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 participants at risk
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 participants at risk
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
Cardiac disorders
bradycardia
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
2.0%
1/50 • Number of events 1 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
|
General disorders
Overnight admission
|
6.0%
3/50 • Number of events 3 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
Other adverse events
| Measure |
Midazolam and Morphine-scopolamine
n=50 participants at risk
Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.
Midazolam: Midazolam is givenas sedation to the Control arm.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Morphine-scopolamine
n=50 participants at risk
Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
morphine-scopolamine: Given as premedication for the Control arm and one of the interventions arms.
|
PCS (Propofol) With Glycopyrronium Bromide
n=50 participants at risk
Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.
Propofol-Lipuro: Propofol is given as sedation to both intervention arms.
Glycopyrrolate: Given as premedication for one of the intervention arms..
|
|---|---|---|---|
|
General disorders
Dizzyness, confusion
|
6.0%
3/50 • Number of events 3 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
12.0%
6/50 • Number of events 6 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
|
General disorders
Fever
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
2.0%
1/50 • Number of events 1 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
|
Cardiac disorders
Chest pain
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
0.00%
0/50 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
2.0%
1/50 • Number of events 1 • From start preparation for bronchospcpy (first drug given) to completing the questionnary QoR-23 on the day after procedure
In the incident report the following grading is used to rate the severity of an incidence: * Mild = aware of the symptoms but they are tolerable * Moderate = symptoms partially affect daily activities * Severe = symptoms significantly affect daily activities The investigator assesses the relationship between the incidence and the study, as defined: • Likely = good reasons and sufficient documentation to suspect caus
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place