Aspiration, RespiratoryNCT02984657
Reverse Trendelenburg Positioning and Its Effect on Outcomes: a Retrospective Study of Consecutive Patients
An observational study of Aspiration, Respiratory and Hypoxia, run by C. Michael Dunham at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether intraoperative reverse Trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration, Respiratory, Hypoxia, Perioperative Period
- What is being tested?
- Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP. and Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Surgical patients from an urban hospital
Who may be able to join
- Patients undergoing endotracheal intubation and general anesthesia
- Age ≥18 years
- Glasgow Coma Scale score ≥13 (prior to tracheal intubation)
- American Society of Anesthesiologists classification I-IV
- Pre-operative pulmonary stability
Who cannot join
- Tracheal intubation prior to emergency department arrival
- Cardiac and thoracic surgical patients
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
About this study
Official title: Evaluation of Operating Room Reverse Trendelenburg Positioning and Its Effect on Postoperative Hypoxemia, Aspiration, and Length of Stay: a Retrospective Study of Consecutive Patients
The purpose of this study is to investigate whether intraoperative reverse Trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.
Read the detailed description
Intraoperative pulmonary aspiration can cause death and lead to morbidity. In addition, reliable estimates of aspiration rates are uncertain. In part, this ambiguity relates to the lack of prospective data. Relevant studies are retrospective chart reviews or results from voluntary reporting databases. Furthermore, aspiration diagnosis can be imprecise. The finding is certain when there is aspiration of bile or particulate matter from the tracheobronchial tree or there is endoscopic visualization. However, the diagnosis is presumptive when there is intraoperative or postoperative development of a new chest x-ray infiltrate and attendant tachypnea, hypoxia, wheezing, or changes in ventilator airway pressures.
Most patients undergoing general endotracheal anesthesia are in the supine or horizontal position. However, evidence from the literature demonstrates that the supine position in mechanically ventilated patients is a risk for aspiration and ventilator associated pneumonia (VAP). During intensive care unit (ICU) mechanical ventilation, the Institute for Healthcare Improvement recommends elevating the head of the bed to prevent pulmonary aspiration and VAP. Other investigations have shown a profound relationship between horizontal positioning and intra-operative aspiration. There is substantial operating room, ICU, and animal investigative evidence that aspiration occurs despite the presence of a cuffed endotracheal tube. Likewise, previous work by this group showed a 30% perioperative hypoxemia rate, which was significantly associated with horizontal positioning. The post-operative length of hospital stay was 2 days longer with hypoxemia, compared to no hypoxemia (p <0.0001) and this represented a total of 300 additional days for the 2 months of the study.
The purpose of this retrospective study is to repeat the investigation after adopting a recent policy change of 10-degree Reverse Trendelenburg position as the routine for surgical patients, unless deemed inappropriate by either the anesthesiology or operating room nursing staff.
- Being tested
- Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP., Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.
- Keywords
- Hypoxemia, Reverse Trendelenburg
- Medical subject headings
- Respiratory Aspiration, Hypoxia, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.Procedure or surgery
RTP, reverse Trendelenburg positioning
Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.Procedure or surgery
RTP, reverse Trendelenburg positioning
| Study group | Role | What they receive |
|---|---|---|
| 2012 patients | Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP. Receives: Procedure: Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP. | |
| 2015 patients | Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP. Receives: Procedure: Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypoxemia
Measured: 48 hours postoperatively
Secondary outcomes (1)
Perioperative pulmonary aspiration
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Aspiration, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. Michael Dunham
- Sponsor type
- University, hospital or other
- Collaborators
- St. Elizabeth Youngstown Hospital
- Responsible party
- Sponsor-investigator, C. Michael Dunham, Mercy Health Ohio
- Investigators
- C. Michael Dunham, MD, Principal investigator, St. Elizabeth Youngstown Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984657
- Sponsor's protocol ID
- 15-023
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dunham CM, Hileman BM, Hutchinson AE, Chance EA, Huang GS. Perioperative hypoxemia is common with horizontal positioning during general anesthesia and is associated with major adverse outcomes: a retrospective study of consecutive patients. BMC Anesthesiol. 2014 Jun 9;14:43. doi: 10.1186/1471-2253-14-43. eCollection 2014.
PubMed 24940115Cotton BR, Smith G. The lower oesophageal sphincter and anaesthesia. Br J Anaesth. 1984 Jan;56(1):37-46. doi: 10.1093/bja/56.1.37. No abstract available.
PubMed 6140931Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia--a prospective survey in France. Can Anaesth Soc J. 1986 May;33(3 Pt 1):336-44. doi: 10.1007/BF03010747.
PubMed 3719435Kozlow JH, Berenholtz SM, Garrett E, Dorman T, Pronovost PJ. Epidemiology and impact of aspiration pneumonia in patients undergoing surgery in Maryland, 1999-2000. Crit Care Med. 2003 Jul;31(7):1930-7. doi: 10.1097/01.CCM.0000069738.73602.5F.
PubMed 12847385Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.
PubMed 10209365Ewig S, Torres A. Prevention and management of ventilator-associated pneumonia. Curr Opin Crit Care. 2002 Feb;8(1):58-69. doi: 10.1097/00075198-200202000-00010.
PubMed 12205408Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomena F, Rodriguez-Roisin R. Pulmonary aspiration of gastric contents in patients receiving mechanical ventilation: the effect of body position. Ann Intern Med. 1992 Apr 1;116(7):540-3. doi: 10.7326/0003-4819-116-7-540.
PubMed 1543307Reali-Forster C, Kolobow T, Giacomini M, Hayashi T, Horiba K, Ferrans VJ. New ultrathin-walled endotracheal tube with a novel laryngeal seal design. Long-term evaluation in sheep. Anesthesiology. 1996 Jan;84(1):162-72; discussion 27A. doi: 10.1097/00000542-199601000-00019.
PubMed 8572330Petring OU, Adelhoj B, Jensen BN, Pedersen NO, Lomholt N. Prevention of silent aspiration due to leaks around cuffs of endotracheal tubes. Anesth Analg. 1986 Jul;65(7):777-80.
PubMed 3717617Seegobin RD, van Hasselt GL. Aspiration beyond endotracheal cuffs. Can Anaesth Soc J. 1986 May;33(3 Pt 1):273-9. doi: 10.1007/BF03010737.
PubMed 3719428Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.
PubMed 12768174Ferrer R, Artigas A. Clinical review: non-antibiotic strategies for preventing ventilator-associated pneumonia. Crit Care. 2002 Feb;6(1):45-51. doi: 10.1186/cc1452. Epub 2001 Jan 11.
PubMed 11940265Keenan SP, Heyland DK, Jacka MJ, Cook D, Dodek P. Ventilator-associated pneumonia. Prevention, diagnosis, and therapy. Crit Care Clin. 2002 Jan;18(1):107-25. doi: 10.1016/s0749-0704(03)00068-x.
PubMed 11910725Koeman M, van der Ven AJ, Ramsay G, Hoepelman IM, Bonten MJ. Ventilator-associated pneumonia: recent issues on pathogenesis, prevention and diagnosis. J Hosp Infect. 2001 Nov;49(3):155-62. doi: 10.1053/jhin.2001.1073. No abstract available.
PubMed 11716631Fernandez-Crehuet R, Diaz-Molina C, de Irala J, Martinez-Concha D, Salcedo-Leal I, Masa-Calles J. Nosocomial infection in an intensive-care unit: identification of risk factors. Infect Control Hosp Epidemiol. 1997 Dec;18(12):825-30.
PubMed 9442407
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Operating Room Reverse Trendelenburg Positioning and Its Effect on Postoperative Hypoxemia, Aspiration, and Length of Stay: a Retrospective Study of Consecutive Patients
- ClinicalTrials.gov ID
- NCT02984657
- Acronym / sponsor ID
- 15-023
- Keywords
- Hypoxemia, Reverse Trendelenburg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- C. Michael DunhamUniversity, hospital or other
- Collaborators
- St. Elizabeth Youngstown Hospital
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether intraoperative reverse Trendelenburg positioning decreases postoperative hypoxemia and perioperative pulmonary aspiration rates.
Detailed description
Intraoperative pulmonary aspiration can cause death and lead to morbidity. In addition, reliable estimates of aspiration rates are uncertain. In part, this ambiguity relates to the lack of prospective data. Relevant studies are retrospective chart reviews or results from voluntary reporting databases. Furthermore, aspiration diagnosis can be imprecise. The finding is certain when there is aspiration of bile or particulate matter from the tracheobronchial tree or there is endoscopic visualization. However, the diagnosis is presumptive when there is intraoperative or postoperative development of a new chest x-ray infiltrate and attendant tachypnea, hypoxia, wheezing, or changes in ventilator airway pressures.
Most patients undergoing general endotracheal anesthesia are in the supine or horizontal position. However, evidence from the literature demonstrates that the supine position in mechanically ventilated patients is a risk for aspiration and ventilator associated pneumonia (VAP). During intensive care unit (ICU) mechanical ventilation, the Institute for Healthcare Improvement recommends elevating the head of the bed to prevent pulmonary aspiration and VAP. Other investigations have shown a profound relationship between horizontal positioning and intra-operative aspiration. There is substantial operating room, ICU, and animal investigative evidence that aspiration occurs despite the presence of a cuffed endotracheal tube. Likewise, previous work by this group showed a 30% perioperative hypoxemia rate, which was significantly associated with horizontal positioning. The post-operative length of hospital stay was 2 days longer with hypoxemia, compared to no hypoxemia (p <0.0001) and this represented a total of 300 additional days for the 2 months of the study.
The purpose of this retrospective study is to repeat the investigation after adopting a recent policy change of 10-degree Reverse Trendelenburg position as the routine for surgical patients, unless deemed inappropriate by either the anesthesiology or operating room nursing staff.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2012 patients | – | Procedure: Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP. |
| 2015 patients | – | Procedure: Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients from an urban hospital
Key inclusion criteria (5 listed)
- Patients undergoing endotracheal intubation and general anesthesia
- Age ≥18 years
- Glasgow Coma Scale score ≥13 (prior to tracheal intubation)
- American Society of Anesthesiologists classification I-IV
- Pre-operative pulmonary stability
Key exclusion criteria (2 listed)
- Tracheal intubation prior to emergency department arrival
- Cardiac and thoracic surgical patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.RTP, reverse Trendelenburg positioning | Procedure or surgery | 2012 patients |
| Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.RTP, reverse Trendelenburg positioning | Procedure or surgery | 2015 patients |
Primary outcome
Postoperative hypoxemia
Time frame: 48 hours postoperatively
1 secondary outcome
Perioperative pulmonary aspiration
Time frame: 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 24940115Dunham CM, Hileman BM, Hutchinson AE, Chance EA, Huang GS. Perioperative hypoxemia is common with horizontal positioning during general anesthesia and is associated with major adverse outcomes: a retrospective study of consecutive patients. BMC Anesthesiol. 2014 Jun 9;14:43. doi: 10.1186/1471-2253-14-43. eCollection 2014.
- Background: PubMed 6140931Cotton BR, Smith G. The lower oesophageal sphincter and anaesthesia. Br J Anaesth. 1984 Jan;56(1):37-46. doi: 10.1093/bja/56.1.37. No abstract available.
- Background: PubMed 3719435Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia--a prospective survey in France. Can Anaesth Soc J. 1986 May;33(3 Pt 1):336-44. doi: 10.1007/BF03010747.
- Background: PubMed 12847385Kozlow JH, Berenholtz SM, Garrett E, Dorman T, Pronovost PJ. Epidemiology and impact of aspiration pneumonia in patients undergoing surgery in Maryland, 1999-2000. Crit Care Med. 2003 Jul;31(7):1930-7. doi: 10.1097/01.CCM.0000069738.73602.5F.
- Background: PubMed 10209365Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.
- Background: PubMed 12205408Ewig S, Torres A. Prevention and management of ventilator-associated pneumonia. Curr Opin Crit Care. 2002 Feb;8(1):58-69. doi: 10.1097/00075198-200202000-00010.
- Background: PubMed 1543307Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomena F, Rodriguez-Roisin R. Pulmonary aspiration of gastric contents in patients receiving mechanical ventilation: the effect of body position. Ann Intern Med. 1992 Apr 1;116(7):540-3. doi: 10.7326/0003-4819-116-7-540.
- Background: PubMed 8572330Reali-Forster C, Kolobow T, Giacomini M, Hayashi T, Horiba K, Ferrans VJ. New ultrathin-walled endotracheal tube with a novel laryngeal seal design. Long-term evaluation in sheep. Anesthesiology. 1996 Jan;84(1):162-72; discussion 27A. doi: 10.1097/00000542-199601000-00019.
- Background: PubMed 3717617Petring OU, Adelhoj B, Jensen BN, Pedersen NO, Lomholt N. Prevention of silent aspiration due to leaks around cuffs of endotracheal tubes. Anesth Analg. 1986 Jul;65(7):777-80.
- Background: PubMed 3719428Seegobin RD, van Hasselt GL. Aspiration beyond endotracheal cuffs. Can Anaesth Soc J. 1986 May;33(3 Pt 1):273-9. doi: 10.1007/BF03010737.
- Background: PubMed 12768174Smith G, Ng A. Gastric reflux and pulmonary aspiration in anaesthesia. Minerva Anestesiol. 2003 May;69(5):402-6.
- Background: PubMed 11940265Ferrer R, Artigas A. Clinical review: non-antibiotic strategies for preventing ventilator-associated pneumonia. Crit Care. 2002 Feb;6(1):45-51. doi: 10.1186/cc1452. Epub 2001 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Michael Dunham, MD principal investigator
St. Elizabeth Youngstown Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration, Respiratory and Hypoxia, run by C. Michael Dunham at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hypoxemia (time frame: 48 hours postoperatively). 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 NCT02984657, which also lists 28 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 7 Dec 2016.